| 8 Jun 2026 | ARTIS icono ceiling. Model Number: 11328100. | Device | Class II | 1 | Ongoing |
| 20 May 2026 | ARTIS icono biplane. Model Number: 11327600. | Device | Class II | 3 | Ongoing |
| 12 Mar 2026 | ARTIS Pheno VE30A and VE40A, Model 10849000 | Device | Class II | 1 | Ongoing |
| 10 Mar 2026 | ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. | Device | Class II | 1 | Ongoing |
| 9 Mar 2026 | ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system | Device | Class II | 2 | Ongoing |
| 29 Dec 2025 | Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02 | Device | Class II | 2 | Ongoing |
| 19 Dec 2025 | SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS | Device | Class II | 4 | Ongoing |
| 5 Dec 2025 | LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 | Device | Class II | 1 | Ongoing |
| 24 Oct 2025 | MAMMOMAT Revelation; | Device | Class II | 3 | Ongoing |
| 1 Oct 2025 | MAGNETOM Cima.X Upgrade. Model Number: 11689304. | Device | Class I | 1 | Ongoing |
| 28 Aug 2025 | Biograph mMR. Model Number: 10433372. | Device | Class I | 15 | Ongoing |
| 12 Aug 2025 | Artis Pheno. Image-Intensified Flouroscopic X-Ray System. | Device | Class II | 1 | Ongoing |
| 4 Jun 2025 | UROSKOP Omnia. Model Number: 10094910 | Device | Class II | 2 | Ongoing |
| 15 May 2025 | ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography, neuro-angiography, general angiography,… | Device | Class II | 4 | Ongoing |
| 2 Jan 2025 | ARTIS One Angiographic X-Ray System | Device | Class II | 1 | Ongoing |
| 15 Aug 2024 | ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software. | Device | Class II | 3 | Ongoing |
| 3 Jul 2024 | Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by… | Device | Class II | 4 | Ongoing |
| 2 Jul 2024 | Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472 | Device | Class II | 4 | Ongoing |
| 31 May 2024 | AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395399 | Device | Class II | 9 | Ongoing |
| 21 Mar 2024 | Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q biplane- 10848282 Artis Q zeego- 10848283 Artis… | Device | Class II | 1 | Ongoing |
| 23 Feb 2024 | ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C | Device | Class II | 3 | Ongoing |
| 29 Nov 2023 | Sensis Vibe Hemo | Device | Class II | 1 | Ongoing |
| 17 Oct 2023 | ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100 | Device | Class II | 1 | Ongoing |
| 5 Oct 2023 | Mobilett Mira wireless (VA20) mobile x-ray system(s) | Device | Class II | 1 | Ongoing |
| 12 Sep 2023 | Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200 | Device | Class II | 2 | Ongoing |
| 1 Sep 2023 | (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845 Used with the following MAGNETOM MRI Systems: MAGENTOM Amira 10836777 & 10838610; MAGENTOM Free.Max 11408424 & 11408425; MAGNETOM Free.Star 11408426… | Device | Class II | 1 | Ongoing |
| 13 Jul 2023 | ACUSON Redwood 2.0 ultrasound systems, REF: 11503314 | Device | Class II | 1 | Ongoing |
| 12 Jul 2023 | The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753. | Device | Class II | 1 | Ongoing |
| 19 Jun 2023 | ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600 | Device | Class II | 3 | Ongoing |
| 5 Jun 2023 | Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. Material #11515088 | Device | Class II | 1 | Ongoing |
| 21 Mar 2023 | ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600 | Device | Class II | 1 | Ongoing |
| 2 Feb 2023 | ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000. | Device | Class II | 1 | Ongoing |
| 2 Feb 2023 | ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000 | Device | Class II | 1 | Ongoing |
| 16 Jan 2023 | SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission | Device | Class II | 3 | Ongoing |
| 22 Dec 2022 | Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 11061610 NA* SOMATOM go.Now Model 11061618 NA* SOMATOM go.Up Model 11061620 SOMATOM go.Up Model 11061628 NA* SOMATOM go.All… | Device | Class II | 1 | Ongoing |
| 21 Dec 2022 | Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200 | Device | Class II | 5 | Ongoing |
| 16 Dec 2022 | System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen… | Device | Class II | 1 | Ongoing |
| 16 Dec 2022 | ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor | Device | Class II | 1 | Ongoing |
| 9 Dec 2022 | AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF | Device | Class II | 3 | Ongoing |
| 23 Nov 2022 | Luminos Agile Max (VE10, VF10, VF11) | Device | Class II | 3 | Ongoing |
| 16 Nov 2022 | Programmable Diagnostic Computer | Device | Class II | 1 | Ongoing |
| 9 Nov 2022 | ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. | Device | Class II | 1 | Ongoing |
| 20 Sep 2022 | ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 | Device | Class II | 1 | Ongoing |
| 10 Aug 2022 | Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355 | Device | Class II | 3 | Ongoing |
| 12 Jul 2022 | AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561; Sensis Vibe Combo 11007642; Sensis recording system is intended to be used as a diagnostic and… | Device | Class III | 1 | Terminated |
| 15 Jun 2022 | Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561 | Device | Class II | 2 | Ongoing |
| 10 Jun 2022 | Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000 | Device | Class II | 1 | Ongoing |
| 24 May 2022 | Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System | Device | Class II | 1 | Terminated |
| 20 May 2022 | Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 | Device | Class II | 1 | Ongoing |
| 13 Apr 2022 | Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620 | Device | Class II | 1 | Ongoing |
| 11 Apr 2022 | Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600 | Device | Class II | 2 | Ongoing |
| 11 Mar 2022 | Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems | Device | Class II | 1 | Terminated |
| 7 Mar 2022 | syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade. | Device | Class II | 4 | Terminated |
| 7 Mar 2022 | Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only , | Device | Class II | 1 | Ongoing |
| 7 Mar 2022 | YSIO X.Pree | Device | Class II | 1 | Ongoing |
| 7 Mar 2022 | SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed… | Device | Class II | 1 | Ongoing |
| 25 Feb 2022 | syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700 | Device | Class II | 1 | Ongoing |
| 25 Feb 2022 | Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600 | Device | Class II | 3 | Ongoing |
| 23 Feb 2022 | Artis zee floor, Model Number 10094135 | Device | Class II | 14 | Ongoing |
| 31 Jan 2022 | Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system | Device | Class II | 1 | Ongoing |
| 19 Jan 2022 | Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneological, Intraoperative, and Urological… | Device | Class II | 1 | Ongoing |
| 9 Dec 2021 | ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815 | Device | Class II | 1 | Terminated |
| 23 Nov 2021 | 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies,… | Device | Class II | 1 | Ongoing |
| 19 Nov 2021 | SOMATOM Confidence -Computed tomography systems Model 10590100 | Device | Class II | 4 | Ongoing |
| 12 Nov 2021 | ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B | Device | Class II | 1 | Ongoing |
| 20 Oct 2021 | Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135 | Device | Class II | 10 | Terminated |
| 12 Oct 2021 | Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000 | Device | Class II | 3 | Terminated |
| 5 Oct 2021 | Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies | Device | Class II | 1 | Ongoing |
| 24 Sep 2021 | Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815 | Device | Class II | 1 | Ongoing |
| 30 Aug 2021 | SOMATOM Force with software syngo.CT VB20 Model #10742326 | Device | Class II | 7 | Terminated |
| 18 Aug 2021 | Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATOM X.cite - Model 11330001 Computed… | Device | Class II | 1 | Ongoing |
| 16 Aug 2021 | syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180 | Device | Class II | 3 | Ongoing |
| 12 Jul 2021 | ACUSON Juniper Diagnostic Ultrasound System | Device | Class II | 1 | Terminated |
| 30 Jun 2021 | Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Angiography systems developed for… | Device | Class II | 1 | Terminated |
| 27 May 2021 | ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000 | Device | Class II | 1 | Ongoing |
| 20 Apr 2021 | Multitom RAX with software version VF10 | Device | Class II | 1 | Terminated |
| 30 Mar 2021 | Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM Artis FA 05904441; AXIOM Artis MP 05904466; AXIOM Artis… | Device | Class II | 1 | Terminated |
| 26 Mar 2021 | Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137 | Device | Class II | 1 | Ongoing |
| 19 Mar 2021 | Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Device | Class II | 1 | Terminated |
| 10 Mar 2021 | Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities. | Device | Class II | 1 | Terminated |
| 4 Mar 2021 | Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data… | Device | Class II | 1 | Terminated |
| 3 Mar 2021 | Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model… | Device | Class II | 1 | Terminated |
| 26 Feb 2021 | Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Device | Class II | 1 | Terminated |
| 4 Feb 2021 | Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems | Device | Class II | 1 | Ongoing |
| 27 Jan 2021 | Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161… | Device | Class II | 1 | Terminated |
| 18 Dec 2020 | ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures. | Device | Class II | 1 | Terminated |
| 30 Nov 2020 | Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno | Device | Class II | 1 | Ongoing |
| 24 Nov 2020 | SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus | Device | Class II | 1 | Terminated |
| 21 Oct 2020 | Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including,… | Device | Class II | 1 | Terminated |
| 21 Sep 2020 | Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for… | Device | Class II | 1 | Terminated |
| 18 Sep 2020 | ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Device | Class II | 1 | Terminated |
| 9 Sep 2020 | Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery). | Device | Class II | 2 | Terminated |
| 19 Aug 2020 | Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180 | Device | Class II | 1 | Terminated |
| 14 Aug 2020 | Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. | Device | Class II | 1 | Terminated |
| 3 Aug 2020 | Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354… | Device | Class II | 1 | Terminated |
| 30 Jul 2020 | Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. | Device | Class II | 2 | Terminated |
| 24 Jul 2020 | Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology. | Device | Class II | 1 | Terminated |
| 14 Jul 2020 | Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications | Device | Class II | 1 | Terminated |
| 24 Jun 2020 | syngo.via RT Image Suite with software versions syngo.via VB30 or VB40 | Device | Class II | 1 | Terminated |
| 22 Jun 2020 | Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus… | Device | Class II | 1 | Terminated |
| 22 May 2020 | ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F | Device | Class II | 1 | Terminated |
| 7 May 2020 | MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals. | Device | Class II | 1 | Terminated |
| 30 Apr 2020 | Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model: 10848281; Artis Q biplane Model:10848282; Artis zee ceiling Model: 10094137; Artis zee floor Model: 10094135 Product Usage: Artis is a family of dedicated… | Device | Class II | 1 | Terminated |
| 23 Apr 2020 | ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600 | Device | Class II | 1 | Terminated |
| 22 Apr 2020 | ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Device | Class II | 1 | Terminated |
| 20 Apr 2020 | Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. | Device | Class II | 3 | Terminated |
| 17 Apr 2020 | Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. | Device | Class II | 2 | Terminated |
| 6 Apr 2020 | System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and… | Device | Class II | 2 | Terminated |
| 18 Feb 2020 | ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13 | Device | Class II | 4 | Terminated |
| 14 Feb 2020 | Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited… | Device | Class II | 3 | Terminated |
| 10 Feb 2020 | Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system. | Device | Class II | 1 | Terminated |
| 24 Jan 2020 | ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be… | Device | Class II | 1 | Terminated |
| 16 Jan 2020 | COHERENCE Oncologist, Model Nos. 07333680 & 07351898 | Device | Class II | 1 | Terminated |
| 8 Jan 2020 | SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. | Device | Class II | 4 | Terminated |
| 8 Jan 2020 | Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as… | Device | Class II | 3 | Terminated |
| 8 Jan 2020 | Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as… | Device | Class II | 3 | Terminated |
| 20 Dec 2019 | Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Device | Class II | 1 | Terminated |
| 25 Nov 2019 | Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application | Device | Class II | 1 | Terminated |
| 14 Nov 2019 | Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C | Device | Class II | 1 | Terminated |
| 7 Oct 2019 | Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700), SOMATOM Confidence (Model #10590100),… | Device | Class II | 1 | Terminated |
| 24 Sep 2019 | SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system | Device | Class II | 1 | Terminated |
| 31 Jul 2019 | SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data | Device | Class II | 7 | Terminated |
| 30 Jul 2019 | Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane 10094141; Artis Q floor 10848280; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen biplane 10848355; Artis zee ceiling 10094137; Artis Q ceiling 10848281;… | Device | Class II | 1 | Terminated |
| 25 Jul 2019 | syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603 | Device | Class II | 1 | Terminated |
| 23 Jul 2019 | Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures | Device | Class II | 1 | Terminated |
| 10 Jul 2019 | Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient, setting up and delivering the treatment… | Device | Class II | 4 | Terminated |
| 9 Jul 2019 | MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914 | Device | Class II | 4 | Terminated |
| 3 Jul 2019 | SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images… | Device | Class II | 7 | Terminated |
| 20 Jun 2019 | Cios Alpha VA20/ VA30 mobile X-Ray systems | Device | Class II | 2 | Terminated |
| 12 Jun 2019 | AXIOM Artis FC, Model Number 5904433 | Device | Class II | 23 | Terminated |
| 6 Jun 2019 | Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135 | Device | Class II | 12 | Terminated |
| 4 Jun 2019 | SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a… | Device | Class II | 4 | Terminated |
| 28 May 2019 | SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a… | Device | Class II | 4 | Terminated |
| 9 Apr 2019 | Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed… | Device | Class II | 4 | Terminated |
| 22 Mar 2019 | Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional… | Device | Class II | 1 | Terminated |
| 21 Mar 2019 | syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the physician in determining the functional… | Device | Class II | 2 | Terminated |
| 20 Mar 2019 | Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR, and PRIMUS running the following: Control Console from software version 13.0.302 and higher; Control Console from… | Device | Class II | 1 | Terminated |
| 18 Mar 2019 | Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic,… | Device | Class II | 1 | Terminated |
| 14 Feb 2019 | SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. | Device | Class II | 4 | Terminated |
| 8 Feb 2019 | Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery). | Device | Class II | 2 | Terminated |
| 28 Jan 2019 | ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver),… | Device | Class II | 4 | Ongoing |
| 30 Nov 2018 | Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. | Device | Class II | 1 | Terminated |
| 29 Nov 2018 | Sensis Vibe System, Model Number 11007642, with software version VD10B. | Device | Class II | 1 | Terminated |
| 26 Oct 2018 | Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Device | Class II | 1 | Terminated |
| 19 Oct 2018 | ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with… | Device | Class II | 3 | Terminated |
| 5 Oct 2018 | EVO Excel, Emission Computed Tomographic System, Material Number 10910501 | Device | Class II | 1 | Terminated |
| 28 Sep 2018 | Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. | Device | Class II | 2 | Terminated |
| 6 Aug 2018 | AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the Siemens Multix PRO- and TOP Systems radiographic exposures of the entire body. | Device | Class II | 3 | Terminated |
| 3 Aug 2018 | Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Integrated (model number 10746667) with… | Device | Class II | 1 | Terminated |
| 29 Jul 2018 | Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355 | Device | Class II | 2 | Terminated |
| 29 Jun 2018 | 3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The ceiling stand can be used… | Device | Class II | 2 | Terminated |
| 22 Jun 2018 | Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.… | Device | Class II | 2 | Terminated |
| 30 May 2018 | ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000 | Device | Class II | 1 | Terminated |
| 29 May 2018 | Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic… | Device | Class II | 1 | Terminated |
| 25 May 2018 | AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures. | Device | Class II | 2 | Terminated |
| 1 May 2018 | ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000 | Device | Class II | 1 | Completed |
| 1 May 2018 | Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures. | Device | Class II | 12 | Terminated |
| 20 Apr 2018 | SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans. | Device | Class II | 2 | Terminated |
| 27 Mar 2018 | Syngo.Via VB20A model 1049610 | Device | Class II | 1 | Terminated |
| 5 Mar 2018 | ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL. | Device | Class II | 1 | Terminated |
| 21 Feb 2018 | Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information. | Device | Class II | 1 | Terminated |
| 20 Feb 2018 | Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.… | Device | Class II | 2 | Terminated |
| 15 Feb 2018 | SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. | Device | Class II | 15 | Terminated |
| 14 Feb 2018 | MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. | Device | Class II | 6 | Terminated |
| 1 Feb 2018 | SOMATOM Emotion 6 (Model 10165888) | Device | Class II | 7 | Terminated |
| 26 Jan 2018 | Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner. | Device | Class II | 1 | Terminated |
| 26 Jan 2018 | ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal… | Device | Class II | 1 | Terminated |
| 12 Jan 2018 | Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Arts one include cardiac angiography, neuro-angiography,… | Device | Class II | 1 | Terminated |
| 10 Jan 2018 | Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. | Device | Class II | 1 | Terminated |
| 8 Jan 2018 | Syngo.via. Medical Device Software. Picture archiving and communications system. | Device | Class II | 1 | Terminated |
| 5 Jan 2018 | AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Device | Class II | 1 | Terminated |
| 8 Nov 2017 | SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system | Device | Class II | 4 | Terminated |
| 7 Nov 2017 | Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. SPECT: To detect or image the distribution… | Device | Class II | 2 | Terminated |
| 2 Oct 2017 | SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis.… | Device | Class II | 2 | Terminated |
| 28 Sep 2017 | Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813. | Device | Class II | 3 | Terminated |
| 18 Sep 2017 | Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices. | Device | Class II | 1 | Terminated |
| 31 Aug 2017 | Syngo.via systems with SW VB20A | Device | Class II | 1 | Terminated |
| 24 Aug 2017 | AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Device | Class II | 1 | Terminated |
| 23 Aug 2017 | Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and… | Device | Class II | 1 | Terminated |
| 22 Aug 2017 | Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus | Device | Class II | 1 | Terminated |
| 18 Aug 2017 | Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended to display, process, read, report, communicate, distribute, store and archive digital… | Device | Class II | 1 | Terminated |
| 25 Jul 2017 | Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in diagnosis and treatment planning. | Device | Class II | 1 | Terminated |
| 6 Jun 2017 | Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355 | Device | Class II | 3 | Terminated |
| 22 May 2017 | Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment… | Device | Class II | 1 | Terminated |
| 16 May 2017 | Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer, | Device | Class II | 1 | Terminated |
| 12 Apr 2017 | AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies. | Device | Class II | 1 | Terminated |
| 30 Mar 2017 | 18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer – 10041227 & 10789400 S1000 – 10441701 S2000 – 10041461 S2000 (Refurb) - 10440017 S3000 – 10441730 Radiology: The ultrasound imaging systems are intended for the following… | Device | Class II | 1 | Terminated |
| 28 Mar 2017 | Artis zee, Angiographic x-ray system | Device | Class II | 1 | Terminated |
| 6 Mar 2017 | Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports… | Device | Class II | 2 | Terminated |
| 27 Feb 2017 | Artis Q and Q.Zen fluoroscopic x-ray system | Device | Class II | 3 | Terminated |
| 22 Feb 2017 | ARTIS Q, Interventional Fluroscopic x-ray system | Device | Class II | 1 | Terminated |
| 20 Feb 2017 | Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular)… | Device | Class II | 4 | Terminated |
| 20 Feb 2017 | Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza… | Device | Class II | 1 | Terminated |
| 14 Feb 2017 | ARTISTE" MV System | Device | Class II | 4 | Terminated |
| 3 Feb 2017 | Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee include cardiac angiography,… | Device | Class II | 1 | Terminated |
| 25 Jan 2017 | ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS” family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. | Device | Class II | 4 | Terminated |
| 25 Jan 2017 | PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer | Device | Class II | 6 | Terminated |
| 11 Jan 2017 | Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft… | Device | Class II | 1 | Terminated |
| 11 Jan 2017 | Syngo.plaza, picture archiving and communications system. | Device | Class II | 1 | Terminated |
| 13 Dec 2016 | Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces… | Device | Class II | 11 | Terminated |
| 8 Dec 2016 | Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis… | Device | Class II | 2 | Terminated |
| 22 Nov 2016 | SOMATOM Scope, Computed tomography x-ray system | Device | Class II | 3 | Terminated |
| 15 Nov 2016 | SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. | Device | Class II | 3 | Terminated |
| 7 Nov 2016 | Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal… | Device | Class II | 1 | Terminated |
| 2 Nov 2016 | SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at… | Device | Class II | 3 | Terminated |
| 1 Nov 2016 | Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee / zeego… | Device | Class II | 3 | Terminated |
| 20 Oct 2016 | SOMATOM Force, System x-ray, tomography, computed | Device | Class II | 1 | Terminated |
| 19 Oct 2016 | SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. | Device | Class II | 2 | Terminated |
| 19 Oct 2016 | SOMATOM Definition AS system, x-ray, tomography, computed | Device | Class II | 2 | Terminated |
| 17 Oct 2016 | Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems | Device | Class II | 1 | Terminated |
| 6 Sep 2016 | Syngo.plaza, Picture Archiving and Communication System | Device | Class II | 2 | Terminated |
| 5 Aug 2016 | e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. | Device | Class II | 1 | Terminated |
| 5 Aug 2016 | Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. | Device | Class II | 2 | Terminated |
| 2 Aug 2016 | Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. | Device | Class II | 2 | Terminated |
| 1 Aug 2016 | Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen and extremities and may be used on pediatric, adult and bariatric… | Device | Class II | 3 | Terminated |
| 26 Jul 2016 | ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. | Device | Class II | 3 | Terminated |
| 13 Jul 2016 | SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system | Device | Class II | 3 | Terminated |
| 13 Jul 2016 | AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures… | Device | Class II | 3 | Terminated |
| 7 Jul 2016 | Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255 Artis zee / zeego and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging… | Device | Class II | 1 | Terminated |
| 23 Jun 2016 | Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images. | Device | Class II | 1 | Terminated |
| 6 Jun 2016 | SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets. | Device | Class II | 1 | Terminated |
| 9 May 2016 | Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173, | Device | Class II | 1 | Terminated |
| 25 Apr 2016 | BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. | Device | Class II | 4 | Terminated |
| 22 Apr 2016 | Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. | Device | Class II | 33 | Terminated |
| 14 Apr 2016 | Syngo Dynamics; Kinetdx Picture Archiving and Communications System | Device | Class II | 1 | Terminated |
| 13 Apr 2016 | MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table. | Device | Class II | 1 | Terminated |
| 8 Apr 2016 | ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816. | Device | Class II | 1 | Terminated |
| 1 Apr 2016 | SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission. | Device | Class II | 1 | Terminated |
| 31 Mar 2016 | E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. | Device | Class II | 1 | Terminated |
| 22 Mar 2016 | SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at different angles or spiral planes taken at different angles. | Device | Class II | 1 | Terminated |
| 11 Mar 2016 | Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography,… | Device | Class II | 1 | Terminated |
| 2 Mar 2016 | Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system. | Device | Class II | 4 | Terminated |
| 26 Feb 2016 | system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Device | Class II | 1 | Terminated |
| 26 Feb 2016 | The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body | Device | Class II | 2 | Terminated |
| 24 Feb 2016 | syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. . | Device | Class II | 1 | Terminated |
| 19 Feb 2016 | AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. | Device | Class II | 2 | Terminated |
| 19 Feb 2016 | Cios Alpha, mobile X-ray system | Device | Class II | 1 | Terminated |
| 18 Feb 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with… | Device | Class II | 12 | Terminated |
| 18 Feb 2016 | AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed… | Device | Class II | 2 | Terminated |
| 16 Feb 2016 | CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic,… | Device | Class II | 1 | Terminated |
| 15 Feb 2016 | Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. | Device | Class II | 8 | Terminated |
| 12 Feb 2016 | Mammomat Inspiration with Tomosynthesis functionality | Device | Class II | 1 | Terminated |
| 29 Jan 2016 | software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images. | Device | Class II | 1 | Terminated |
| 25 Jan 2016 | Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report… | Device | Class II | 1 | Terminated |
| 18 Jan 2016 | A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. | Device | Class II | 1 | Terminated |
| 31 Dec 2015 | The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. | Device | Class II | 1 | Terminated |
| 22 Dec 2015 | Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems. | Device | Class II | 1 | Terminated |
| 7 Dec 2015 | MAGNETOM systems, magnetic resonance diagnostic devices (MRDD). | Device | Class II | 1 | Terminated |
| 18 Nov 2015 | Software version VD10E for Syngo X-Workplace; Picture archiving and communication system. | Device | Class II | 1 | Terminated |
| 17 Nov 2015 | Syngo Imaging XS is a Picture Archiving and Communication System (PACS) | Device | Class II | 1 | Terminated |
| 30 Oct 2015 | Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures. | Device | Class II | 1 | Terminated |
| 28 Oct 2015 | Syngo Imaging VB36D_HF02. Radiological image processing system. | Device | Class II | 1 | Terminated |
| 7 Oct 2015 | ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes. | Device | Class II | 1 | Terminated |
| 24 Sep 2015 | MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis. | Device | Class II | 1 | Terminated |
| 5 Sep 2015 | ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844 – ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) Radiology: The Siemens ACUSON X700 ultrasound imaging system is intended for the following… | Device | Class II | 1 | Terminated |
| 19 Aug 2015 | ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal… | Device | Class II | 1 | Terminated |
| 18 Aug 2015 | SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients. | Device | Class II | 1 | Terminated |
| 17 Aug 2015 | CIOS ALPHA; image intensified fluoroscopic x-ray system | Device | Class II | 1 | Terminated |
| 14 Aug 2015 | SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. | Device | Class II | 3 | Terminated |
| 11 Aug 2015 | Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of… | Device | Class II | 1 | Terminated |
| 5 Aug 2015 | ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the… | Device | Class II | 1 | Terminated |
| 31 Jul 2015 | Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile/ transportable imaging environment. | Device | Class II | 3 | Terminated |
| 14 Jul 2015 | Biograph mCT S(40)-4R, Model Number 10248671 | Device | Class II | 8 | Terminated |
| 6 Jul 2015 | Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.… | Device | Class II | 1 | Terminated |
| 30 Jun 2015 | Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Device | Class II | 1 | Terminated |
| 29 Jun 2015 | ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6C1HD - model numbers: 10442008 6C1HD Needle Guide, S3000; 10440586 6C1 HD Biopsy Guide, S2000 18L6 - model numbers: 10442007 18L6 Biopsy Guide, S3000 10044200 S2000 Biopsy Starter Kit, 18L6 HD 10855189 18L6 HD Biopsy Starter… | Device | Class II | 1 | Terminated |
| 29 Jun 2015 | Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational… | Device | Class II | 3 | Terminated |
| 26 Jun 2015 | e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. | Device | Class II | 1 | Terminated |
| 25 Jun 2015 | ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 – S 2000 system 10441730 – S 3000 system 10441701 – S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal,… | Device | Class II | 1 | Terminated |
| 25 Jun 2015 | ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative,… | Device | Class II | 1 | Terminated |
| 11 Jun 2015 | SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. | Device | Class II | 1 | Terminated |
| 4 Jun 2015 | SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles. | Device | Class II | 2 | Terminated |
| 29 May 2015 | ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel,… | Device | Class II | 1 | Terminated |
| 22 May 2015 | Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro… | Device | Class II | 1 | Terminated |
| 15 May 2015 | Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. | Device | Class II | 1 | Terminated |
| 6 May 2015 | syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration. The system electronically displays stores, retrieves, transfers, exchanges, and prints. | Device | Class II | 1 | Terminated |
| 5 May 2015 | ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of cancer. | Device | Class II | 1 | Terminated |
| 5 May 2015 | Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic,… | Device | Class II | 1 | Terminated |
| 20 Apr 2015 | SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles. | Device | Class II | 3 | Terminated |
| 14 Apr 2015 | AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen,… | Device | Class II | 1 | Terminated |
| 13 Apr 2015 | SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small… | Device | Class II | 4 | Terminated |
| 19 Mar 2015 | Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general… | Device | Class II | 1 | Terminated |
| 9 Mar 2015 | MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the… | Device | Class II | 1 | Terminated |
| 18 Feb 2015 | Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. | Device | Class II | 1 | Terminated |
| 6 Feb 2015 | SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: The intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at… | Device | Class II | 1 | Terminated |
| 21 Jan 2015 | Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories | Device | Class II | 1 | Terminated |
| 16 Jan 2015 | Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose… | Device | Class II | 1 | Terminated |
| 13 Jan 2015 | Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM… | Device | Class II | 1 | Terminated |
| 12 Jan 2015 | ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image. | Device | Class II | 1 | Terminated |
| 12 Jan 2015 | ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative… | Device | Class II | 1 | Terminated |
| 2 Jan 2015 | Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer | Device | Class II | 1 | Terminated |
| 19 Dec 2014 | LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON M2 6300,… | Device | Class II | 1 | Terminated |
| 15 Dec 2014 | Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and… | Device | Class II | 1 | Terminated |
| 3 Dec 2014 | SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles. | Device | Class II | 1 | Terminated |
| 3 Dec 2014 | Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac… | Device | Class II | 1 | Terminated |
| 2 Dec 2014 | Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON 6300, MEVATRON MDX-2, MEVATRON MD-2,… | Device | Class II | 1 | Terminated |
| 19 Nov 2014 | ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. | Device | Class II | 1 | Terminated |
| 13 Nov 2014 | Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. | Device | Class II | 5 | Terminated |
| 11 Nov 2014 | Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. | Device | Class II | 1 | Terminated |
| 28 Oct 2014 | Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation. | Device | Class II | 1 | Terminated |
| 10 Oct 2014 | Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer. | Device | Class II | 1 | Terminated |
| 23 Sep 2014 | Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac… | Device | Class II | 1 | Terminated |
| 18 Sep 2014 | Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation. | Device | Class II | 1 | Terminated |
| 17 Sep 2014 | Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac… | Device | Class II | 1 | Terminated |
| 2 Sep 2014 | Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used… | Device | Class II | 4 | Terminated |
| 27 Aug 2014 | The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. | Device | Class II | 1 | Terminated |
| 13 Aug 2014 | V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications | Device | Class II | 1 | Terminated |
| 12 Aug 2014 | AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric… | Device | Class II | 1 | Terminated |
| 12 Aug 2014 | The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease,… | Device | Class II | 3 | Terminated |
| 28 Jul 2014 | The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, WB and SPECT applications. The Symbia… | Device | Class II | 2 | Terminated |
| 7 Jul 2014 | Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. | Device | Class II | 1 | Terminated |
| 30 Jun 2014 | Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also… | Device | Class II | 1 | Terminated |
| 17 Jun 2014 | Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. | Device | Class II | 1 | Terminated |
| 5 Jun 2014 | AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac… | Device | Class II | 1 | Terminated |
| 5 Jun 2014 | Artis zee and Artis zeego systems. x-ray, angiographic system | Device | Class II | 1 | Terminated |
| 3 Jun 2014 | ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems. | Device | Class II | 1 | Terminated |
| 28 May 2014 | Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option. | Device | Class II | 1 | Terminated |
| 15 May 2014 | Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer. | Device | Class II | 1 | Terminated |
| 9 May 2014 | Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric… | Device | Class II | 1 | Terminated |
| 9 May 2014 | Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the central X-ray department. | Device | Class II | 1 | Terminated |
| 6 May 2014 | Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer. | Device | Class II | 1 | Terminated |
| 25 Apr 2014 | MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. | Device | Class II | 1 | Terminated |
| 24 Apr 2014 | MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. | Device | Class II | 1 | Terminated |
| 23 Apr 2014 | e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear medicine diagnostic device. | Device | Class II | 2 | Terminated |
| 23 Apr 2014 | ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system. | Device | Class II | 1 | Terminated |
| 23 Apr 2014 | ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system. | Device | Class II | 1 | Terminated |
| 11 Apr 2014 | AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a… | Device | Class II | 1 | Terminated |
| 8 Apr 2014 | e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. | Device | Class II | 1 | Terminated |
| 3 Apr 2014 | syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of… | Device | Class II | 1 | Terminated |
| 3 Apr 2014 | Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. | Device | Class II | 1 | Terminated |
| 2 Apr 2014 | Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system. | Device | Class II | 1 | Terminated |
| 1 Apr 2014 | 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer. | Device | Class II | 1 | Terminated |
| 1 Apr 2014 | Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer | Device | Class II | 1 | Terminated |
| 21 Mar 2014 | Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. | Device | Class II | 1 | Terminated |
| 7 Mar 2014 | Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. | Device | Class II | 1 | Terminated |
| 5 Mar 2014 | AXIOM Vertix MD Trauma systems radiographic X-ray | Device | Class II | 1 | Terminated |
| 5 Mar 2014 | Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies. | Device | Class II | 1 | Terminated |
| 13 Feb 2014 | MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. | Device | Class II | 1 | Terminated |
| 7 Feb 2014 | Artis Zee Angiographic x-ray systems. | Device | Class II | 1 | Terminated |
| 7 Feb 2014 | AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Device | Class II | 1 | Terminated |
| 27 Jan 2014 | syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673 | Device | Class II | 1 | Terminated |
| 22 Dec 2013 | ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pediatric, Transesophageal, Adult Cephalic,… | Device | Class II | 1 | Terminated |
| 22 Dec 2013 | ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system. | Device | Class II | 1 | Terminated |
| 16 Dec 2013 | Siemens Artis zee Ceiling Systems. Angiographic x-ray system. | Device | Class II | 1 | Terminated |
| 11 Dec 2013 | SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de l’Esplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT and SIMVIEW NT with IDI is a radiation therapy… | Device | Class II | 1 | Terminated |
| 5 Dec 2013 | Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray | Device | Class II | 1 | Terminated |
| 5 Dec 2013 | PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to… | Device | Class II | 1 | Terminated |
| 15 Nov 2013 | Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology. | Device | Class II | 1 | Terminated |
| 28 Oct 2013 | Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ. | Device | Class II | 2 | Terminated |
| 23 Oct 2013 | SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR… | Device | Class II | 2 | Terminated |
| 11 Sep 2013 | The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. | Device | Class II | 1 | Terminated |
| 3 Sep 2013 | Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system | Device | Class II | 1 | Terminated |
| 3 Sep 2013 | (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system | Device | Class II | 1 | Terminated |
| 28 Aug 2013 | Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system | Device | Class II | 1 | Terminated |
| 16 Aug 2013 | Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT component is intended to produce corss-sectional images of the… | Device | Class II | 2 | Terminated |
| 18 Jul 2013 | PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083. Product Usage: The intended use of the SIEMENS branded, ARTISTE”, ONCOR” and PRIMUS” family of linear accelerator systems is to deliver X-ray photon and electron radiation for the… | Device | Class II | 1 | Terminated |
| 10 Jul 2013 | Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical… | Device | Class II | 1 | Terminated |
| 26 Jun 2013 | ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system | Device | Class II | 1 | Terminated |
| 10 Jun 2013 | syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. syngo Dynamics is not intended to be used for reading mammography… | Device | Class II | 1 | Terminated |
| 5 Jun 2013 | Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging. | Device | Class II | 1 | Terminated |
| 29 May 2013 | Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment… | Device | Class II | 1 | Terminated |
| 29 May 2013 | ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Device | Class II | 1 | Terminated |
| 13 May 2013 | Siemens AXIOM Artis zeego x-ray, angiographic system | Device | Class II | 1 | Terminated |
| 7 May 2013 | Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system | Device | Class II | 1 | Terminated |
| 6 May 2013 | Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems | Device | Class II | 1 | Terminated |
| 2 May 2013 | Mobiletta Mira Mobile X-ray System | Device | Class II | 1 | Terminated |
| 26 Apr 2013 | Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system. | Device | Class II | 1 | Terminated |
| 4 Apr 2013 | Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Device | Class II | 1 | Terminated |
| 28 Mar 2013 | Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal,… | Device | Class II | 1 | Terminated |
| 8 Mar 2013 | Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system | Device | Class II | 1 | Terminated |
| 5 Mar 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR” and PRIMUS” family of… | Device | Class II | 9 | Terminated |
| 4 Mar 2013 | Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system | Device | Class II | 1 | Terminated |
| 28 Feb 2013 | Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography | Device | Class II | 1 | Terminated |
| 31 Jan 2013 | Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system | Device | Class II | 1 | Terminated |
| 21 Jan 2013 | Artis zee systems x-ray, angiographic system | Device | Class II | 1 | Terminated |
| 18 Jan 2013 | ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image. | Device | Class II | 1 | Terminated |
| 17 Jan 2013 | SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY. | Device | Class II | 1 | Terminated |
| 15 Jan 2013 | Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system. | Device | Class II | 1 | Terminated |
| 20 Dec 2012 | ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE” and ONCOR” family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Device | Class II | 1 | Terminated |
| 27 Nov 2012 | Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system. | Device | Class II | 1 | Terminated |
| 26 Nov 2012 | Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system | Device | Class II | 1 | Terminated |
| 23 Oct 2012 | The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and… | Device | Class II | 2 | Terminated |
| 10 Oct 2012 | Siemens Mobilette Mira, intended use as Mobile x-ray system. | Device | Class II | 1 | Terminated |
| 10 Oct 2012 | MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light | Device | Class II | 1 | Terminated |
| 5 Oct 2012 | Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration, as well as multiple… | Device | Class II | 1 | Terminated |
| 12 Sep 2012 | Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager | Device | Class II | 1 | Terminated |
| 21 Aug 2012 | Siemens Mobilett Mira. Mobile X-Ray System. | Device | Class II | 1 | Terminated |
| 18 Jul 2012 | syngo Imaging XS. Radiological image processing system. | Device | Class II | 1 | Terminated |
| 18 Jul 2012 | syngo.plaza, Model number 10592457. Intended use: radiological image processing system. | Device | Class II | 1 | Terminated |
| 13 Jul 2012 | syngo Dynamics Version 9.5 | Device | Class II | 1 | Terminated |
| 11 Jul 2012 | ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative,… | Device | Class II | 1 | Terminated |
| 25 Jun 2012 | ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Device | Class II | 1 | Terminated |
| 20 Jun 2012 | Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System | Device | Class II | 1 | Terminated |
| 6 Jun 2012 | Siemens syngo.plaza radiological image processing system. | Device | Class II | 1 | Terminated |
| 11 May 2012 | ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal,… | Device | Class II | 1 | Terminated |
| 30 Apr 2012 | Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system | Device | Class II | 1 | Terminated |
| 30 Apr 2012 | Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system | Device | Class II | 1 | Terminated |
| 11 Apr 2012 | Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. | Device | Class II | 2 | Terminated |
| 24 Feb 2012 | Siemens syngo.plaza. Radiological image processing system | Device | Class II | 1 | Terminated |
| 8 Aug 2011 | Siemens syngo.plaza image processing system image processing radiological system | Device | Class II | 1 | Terminated |