Merge Universal Viewer (MUV)
Merge Healthcare Incorporated
Merge Healthcare Incorporated
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2183926 | 1000116130 | Merge Healthcare Incorporated | 1 | Y | 2026-01-01 | 900 Walnut Ridge Dr Hartland WI US 53029 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 80394 | 1095969671 | K913929 | DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM | HKI | 1991-11-27 |
| 80394 | 1570073108 | K250301 | Merge Universal Viewer (MUV) | LLZ | 2025-04-14 |
| 80394 | 1539743836 | K233326 | Merge Hemo, Model RCSV2 | DQK | 2024-06-21 |
| 80394 | 1019195841 | K203104 | IBM iConnect Access | LLZ | 2021-01-26 |
| 80394 | 1741531599 | K192455 | Merge PACS | LLZ | 2019-10-17 |
| 80394 | 1807073152 | K192276 | Merge Cardio | LLZ | 2019-09-20 |
| 80394 | 1720641010 | K182290 | IBM iConnect Access | LLZ | 2018-09-25 |
| 80394 | 1788413433 | K173475 | Merge PACS | LLZ | 2017-12-08 |
| 80394 | 1510501176 | K152864 | Merge Hemo | DQK | 2016-04-07 |
| 80394 | 1071932922 | K110006 | OIS SYMPHONY IMAGE MANAGMENT SYSTEM | NFJ | 2011-05-18 |
| 80394 | 1379796486 | K092954 | CADSTREAM VERSION 5 | LLZ | 2009-11-06 |
| 80394 | 1752053600 | K092915 | CEDARA WEBACCESS, MODEL: 2.4 | LLZ | 2010-06-23 |
| 80394 | 1909284535 | K082421 | HEARTSUITE HEMODYNAMICS 7.10 | DQK | 2008-12-17 |
| 80394 | 1890464754 | K082144 | AMICAS PACS, VERSION 6.0 | LLZ | 2008-09-05 |
| 80394 | 1555549161 | K053281 | EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) | LLZ | 2005-12-07 |
| 80394 | 1801870079 | K051649 | VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 | LLZ | 2005-08-02 |
| 80394 | 1847595266 | K041935 | DR SYSTEMS PACS, RELEASE 6.1 | LLZ | 2004-08-16 |
| 80394 | 1070820625 | K022881 | CEDARA I-SOFTVIEW | LLZ | 2002-10-22 |
| 80394 | 2068667053 | K020995 | EFILM WORKSTATION WITH MODULES | LLZ | 2002-04-12 |
| 80394 | 1945781992 | K012211 | EFILM WORKSTATION | LLZ | 2001-07-31 |
| 80394 | 1355444258 |
Product Codes Associated With Registrations#
PMN#
Merge Hemo, Model RCSV2
Merge Healthcare Incorporated
IBM iConnect Access
Merge Healthcare Incorporated
Merge PACS
Merge Healthcare Incorporated
Merge Cardio
Merge Healthcare Incorporated
IBM IConnect Access
Merge Healthcare Incorporated
Merge PACS
Merge Healthcare Incorporated
Merge Hemo
MERGE HEALTHCARE INCORPORATED
GUDID#
Merge Universal Viewer - Correcting entry.
2021-09-21
RadSuite - 8.32
2019-09-25
Merge PACS - 9.5
2026-05-07
IBM iConnect Access - 7.0
2018-10-26
Merge OrthoCase - 3.7.5
2018-09-21
IBM iConnect Access - 7.1
2019-04-30
Merge OrthoTemplates - Software implant template
2023-06-09
Merge iConnect Access - Software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data.
2017-10-17
Merge iConnect Access - Standalone software application.
2016-12-12
iConnect Access - Stand alone software application.
2019-05-10
Merge Cardio - Standalone software application
2017-02-10
Merge Cardio - Standalone software application
2017-09-05
Merge Cardio - Standalone software application.
2017-01-12
Merge Hemo - 10.3
2020-04-23
CADstream - Standalone Software Application
2019-04-26
CADstream - Standalone Software Application
2021-02-08
CADstream - Standalone Software Application
2021-09-21
Merge HEMO - 10.1
2017-10-19
Merge Hemo - 10.0.4
2016-11-30
Merge Hemo - 9.4
2021-09-21
Merge Hemo - 10.2
2019-06-27
Merge Cardio - 12.5
2025-11-24
Merge PACS - 9.4
2025-09-03
Merge PACS - 9.3
2025-08-20
Merge Universal Viewer - 9.1
2025-08-01
CADstream - Standalone software application
2024-11-14
Merge Hemo - RCSV2
2024-09-10
Merge PACS - 9.2
2024-07-01
Merge Universal Viewer - 8.5
2024-04-30
Merge Universal Viewer - 8.4
2023-08-30
Merge Cardio - Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system. The Merge Cardio system is intended to allow authorized health care professionals the ability to import, export, review, analyze, quantify, report and manage digital cardiovascular images, documents, and data related to cardiology. The study list supports workflow management by providing a robust study list with configurable informational columns supporting navigation, current study and reporting status, and prior study availability and relevancy. The system offers standard image controls such as brightness, contrast, zoom, and cine playback controls; as well modality specific tools such as R-wave sync and frame rate sync. The system allows users to review images, annotate images, perform digital subtraction on XA images, perform quantitative measurements on images (based on modality and anatomy including quantitative coronary analysis, left ventricular analysis, distance, angle, velocity, slope, area, velocity time integral, and volume), derive US measurements, and generate clinical reports. The system provides the ability to create clinical reports for Adult Echo, Pediatric Echo, Vascular US, Nuclear Medicine, Cath/Peripheral Invasive, Electrophysiology, Cardiac CT, and Cardiac MR. Merge Cardio runs on standard information technology hardware and software, using standard technology operating systems and user interfaces. Communication and data exchange are done using standard protocols.
2024-02-05
eFilm Workstation - 4.2.1
2017-10-31
Merge Eye Care PACS - Standalone software application
2017-02-10
Merge Eye Care PACS - Standalone software application
2016-12-01
Merge Eye Care PACS - Standalone software application
2017-08-24
eFilm Lite - 4.2.1
2017-10-31
eFilm Lite - Standalone software application
2016-12-01
eFilm Workstation - Standalone software application
2016-12-01
Merge Eye Care PACS - Standalone software application
2016-12-01
eFilm Lite - Standalone software application
2021-02-08