| 22 Jul 2026 | Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation | Device | Class II | 1 | Ongoing |
| 30 Jun 2026 | Merge PACS, medical imaging diagnostic workstation | Device | Class II | 2 | Ongoing |
| 11 Aug 2025 | Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from… | Device | Class II | 1 | Ongoing |
| 19 Feb 2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system. | Device | Class II | 5 | Ongoing |
| 23 Jul 2021 | Merge Hemo, Software packages 10.2, 10.3, and 10.4 | Device | Class II | 1 | Terminated |
| 6 Aug 2020 | Merge PACS | Device | Class II | 1 | Terminated |
| 8 May 2020 | Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images,… | Device | Class II | 1 | Terminated |
| 11 Jul 2019 | Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 | Device | Class II | 2 | Terminated |
| 20 Dec 2018 | The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product Usage: The WinStation Retinal Imager has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior… | Device | Class II | 1 | Terminated |
| 14 Aug 2017 | Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from… | Device | Class II | 1 | Terminated |
| 7 Aug 2017 | Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from… | Device | Class II | 1 | Terminated |
| 13 Jun 2017 | Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication… | Device | Class II | 1 | Terminated |
| 24 May 2017 | Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI. | Device | Class II | 1 | Terminated |
| 24 May 2017 | Merge OrthoPACS software. | Device | Class II | 1 | Terminated |
| 8 May 2017 | Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography | Device | Class II | 1 | Terminated |
| 8 May 2017 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. | Device | Class II | 1 | Terminated |
| 6 Apr 2017 | Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo System. | Device | Class II | 1 | Terminated |
| 23 Jan 2017 | Merge LIS | Device | Class II | 1 | Terminated |
| 9 Dec 2016 | Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations. | Device | Class II | 1 | Terminated |
| 9 Dec 2016 | Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior | Device | Class II | 1 | Terminated |
| 20 Oct 2016 | Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices,… | Device | Class II | 1 | Terminated |
| 14 Jul 2016 | Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion,… | Device | Class II | 1 | Terminated |
| 25 May 2016 | iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI. | Device | Class II | 1 | Terminated |
| 15 Apr 2016 | Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported. | Device | Class II | 1 | Terminated |
| 13 Apr 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information. | Device | Class II | 1 | Terminated |
| 8 Apr 2016 | DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. | Device | Class II | 1 | Terminated |
| 8 Apr 2016 | DR Systems Unity PACS software, now known as Merge Unity PACS | Device | Class II | 1 | Terminated |
| 4 Apr 2016 | iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI. | Device | Class II | 1 | Terminated |
| 4 Apr 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. | Device | Class II | 1 | Terminated |
| 4 Apr 2016 | iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare. | Device | Class II | 1 | Terminated |
| 4 Apr 2016 | Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data. | Device | Class II | 1 | Terminated |
| 4 Apr 2016 | Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure | Device | Class II | 1 | Terminated |
| 4 Apr 2016 | Merge Eye Station and Merge Eye Care PACS. | Device | Class II | 1 | Terminated |
| 4 Apr 2016 | SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2,… | Device | Class II | 4 | Terminated |
| 4 Apr 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. | Device | Class II | 1 | Terminated |
| 4 Apr 2016 | Merge PACS software. The firm name on the label is Merge Healthcare. | Device | Class II | 1 | Terminated |
| 4 Apr 2016 | Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare. | Device | Class II | 1 | Terminated |
| 4 Apr 2016 | iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data | Device | Class II | 1 | Terminated |
| 4 Apr 2016 | Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU). | Device | Class II | 1 | Terminated |
| 4 Apr 2016 | iConnect Enterprise Archive software. | Device | Class II | 1 | Terminated |
| 4 Apr 2016 | Merge Cardio software. | Device | Class II | 1 | Terminated |
| 4 Apr 2016 | Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI. | Device | Class II | 1 | Terminated |
| 28 Mar 2016 | Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure | Device | Class II | 1 | Terminated |
| 28 Mar 2016 | Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography. | Device | Class II | 1 | Terminated |
| 28 Mar 2016 | Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography. | Device | Class II | 1 | Terminated |
| 28 Mar 2016 | Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI. | Device | Class II | 1 | Terminated |
| 28 Mar 2016 | Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on… | Device | Class II | 1 | Terminated |
| 28 Mar 2016 | Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of… | Device | Class II | 1 | Terminated |
| 10 Mar 2016 | The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software. | Device | Class II | 1 | Terminated |
| 9 Feb 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system. | Device | Class II | 1 | Terminated |
| 5 Feb 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. | Device | Class II | 1 | Terminated |
| 31 Jan 2016 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. | Device | Class II | 1 | Terminated |
| 31 Jan 2016 | Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI. | Device | Class II | 1 | Terminated |
| 30 Jan 2016 | iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks. | Device | Class II | 2 | Terminated |
| 30 Jan 2016 | CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI. | Device | Class II | 1 | Terminated |
| 30 Jan 2016 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. | Device | Class II | 2 | Terminated |
| 30 Jan 2016 | Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI. | Device | Class II | 1 | Terminated |
| 30 Jan 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. | Device | Class II | 1 | Terminated |
| 30 Jan 2016 | Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications | Device | Class II | 1 | Terminated |
| 30 Jan 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. | Device | Class II | 1 | Terminated |
| 30 Jan 2016 | Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system. | Device | Class II | 1 | Terminated |
| 30 Jan 2016 | Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and… | Device | Class II | 1 | Terminated |
| 17 Dec 2015 | RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E,… | Device | Class II | 1 | Terminated |
| 17 Nov 2015 | Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. | Device | Class II | 1 | Terminated |
| 26 Oct 2015 | Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. | Device | Class II | 2 | Terminated |
| 15 Oct 2015 | DR Systems Unity PACS software, now known as Merge Unity PACS software. | Device | Class II | 1 | Terminated |
| 8 Oct 2015 | Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI. | Device | Class II | 1 | Terminated |
| 1 Oct 2015 | Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, hemodynamic studies and reports, measurements (via import from DICOM Structured reporting, text files or optical… | Device | Class II | 1 | Terminated |
| 22 Sep 2015 | Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI. | Device | Class II | 1 | Terminated |
| 22 Sep 2015 | Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of… | Device | Class II | 1 | Terminated |
| 23 Jul 2015 | Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. | Device | Class II | 1 | Terminated |
| 31 May 2015 | The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software. | Device | Class II | 1 | Terminated |
| 9 Apr 2015 | Merge RadSuite software. Radiological image processing system. | Device | Class II | 1 | Terminated |
| 30 Mar 2015 | Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system. | Device | Class II | 1 | Terminated |
| 5 Mar 2015 | Merge LIS software. | Device | Class II | 1 | Terminated |
| 21 Jan 2015 | Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. | Device | Class II | 1 | Terminated |
| 29 Sep 2014 | Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is… | Device | Class II | 1 | Terminated |
| 28 Aug 2014 | eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (including… | Device | Class II | 1 | Terminated |
| 30 Apr 2014 | Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of… | Device | Class II | 1 | Terminated |
| 6 May 2013 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. | Device | Class II | 1 | Terminated |
| 1 Nov 2012 | CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools. | Device | Class II | 1 | Terminated |
| 2 Jul 2012 | Merge HEMO software. | Device | Class II | 1 | Terminated |
| 28 Oct 2011 | Fusion Workstation.; Indicated for the transmission and review of radiological images. | Device | Class II | 1 | Terminated |
| 19 Oct 2011 | CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools. | Device | Class II | 1 | Terminated |