Company ยท US
Merge Healthcare, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2025. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
96recalls (3 in 12 months)
86recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLZ | System, Image Processing, Radiological | 67 |
| DQK | Computer, Diagnostic, Programmable | 17 |
| LMB | Device, Digital Image Storage, Radiological | 5 |
| NFJ | System, Image Management, Ophthalmic | 4 |
| DQA | Oximeter | 3 |
| HKI | Camera, Ophthalmic, Ac-Powered | 3 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 2 |
| OUG | Medical Device Data System | 2 |
| NSX | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 14, 2025 | K250301 | Merge Universal Viewer (MUV) Merge Healthcare Incorporated | LLZ |
| Jun 21, 2024 | K233326 | Merge Hemo, Model RCSV2 Merge Healthcare Incorporated | DQK |
| Jan 26, 2021 | K203104 | IBM iConnect Access Merge Healthcare Incorporated | LLZ |
| Oct 17, 2019 | K192455 | Merge PACS Merge Healthcare Incorporated | LLZ |
| Sep 20, 2019 | K192276 | Merge Cardio Merge Healthcare Incorporated | LLZ |
| Sep 25, 2018 | K182290 | IBM iConnect Access Merge Healthcare Incorporated | LLZ |
| Dec 8, 2017 | K173475 | Merge PACS Merge Healthcare Incorporated | LLZ |
| Apr 7, 2016 | K152864 | Merge Hemo Merge Healthcare Incorporated | DQK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2026 | Merge Healthcare, Inc. Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation Open, Classified |
LLZ | K192455 |
| Aug 4, 2026 | Merge Healthcare, Inc. Merge OrthoPACS, medical imaging diagnostic workstation Open, Classified |
LLZ | K192455 |
| Aug 4, 2026 | Merge Healthcare, Inc. Merge PACS, medical imaging diagnostic workstation Open, Classified |
LLZ | K192455 |
| Sep 4, 2025 | Merge Healthcare, Inc. 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 mo Open, Classified |
DQK | K233326 |
| Mar 20, 2025 | Merge Healthcare, Inc. Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integra Open, Classified |
LLZ | K192206 |
| Mar 20, 2025 | Merge Healthcare, Inc. VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and commun Open, Classified |
LLZ | K051649 |
| Mar 20, 2025 | Merge Healthcare, Inc. VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The VERICIS is an integrated cardiovascular information system classified as a pictur Open, Classified |
LLZ | K051649 |
| Mar 20, 2025 | Merge Healthcare, Inc. VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified a Open, Classified |
LLZ | K051649 |
| Mar 20, 2025 | Merge Healthcare, Inc. 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 communicat Open, Classified |
LLZ | K051649 |
| Jul 23, 2021 | Merge Healthcare, Inc. Merge Hemo, Software packages 10.2, 10.3, and 10.4 Terminated |
DQK | K152864 |
| Aug 6, 2020 | Merge Healthcare, Inc. Merge PACS Terminated |
LLZ | K192455 |
| May 8, 2020 | Merge Healthcare, Inc. 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, pr Terminated |
LLZ | K051649 |
| Jul 11, 2019 | Merge Healthcare, Inc. Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1 Terminated |
LLZ | K173475 |
| Jul 11, 2019 | Merge Healthcare, Inc. Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 Terminated |
LLZ | K173475 |
| Feb 25, 2019 | Merge Healthcare, Inc. 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 camera Terminated |
HKI | K982689 |
| Aug 18, 2017 | Merge Healthcare, Inc. 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 Terminated |
LLZ | K041935 K143318 |
| Aug 7, 2017 | Merge Healthcare, Inc. 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 Terminated |
LLZ | K041935 K143318 |
| Jul 10, 2017 | Merge Healthcare, Inc. 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 Ca Terminated |
NFJ | K110006 |
| May 25, 2017 | Merge Healthcare, Inc. 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 e Terminated |
JQP | None listed |
| May 24, 2017 | Merge Healthcare, Inc. Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K022881 K082144 +1 |
| May 24, 2017 | Merge Healthcare, Inc. Merge OrthoPACS software. Terminated |
LLZ | None listed |
| May 22, 2017 | Merge Healthcare, Inc. 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. Terminated |
LLZ | K051649 |
| May 8, 2017 | Merge Healthcare, Inc. 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, includi Terminated |
LLZ | K082144 |
| May 8, 2017 | Merge Healthcare, Inc. Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K082144 |
| May 2, 2017 | Merge Healthcare, Inc. 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 Terminated |
DQK | K082421 |
| Apr 11, 2017 | Merge Healthcare, Inc. 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 catheteriza Terminated |
DQK | K082421 |
| Apr 6, 2017 | Merge Healthcare, Inc. 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. Terminated |
DQK | K152864 |
| Apr 5, 2017 | Merge Healthcare, Inc. iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Terminated |
LMB | None listed |
| Mar 20, 2017 | Merge Healthcare, Inc. Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K051649 |
| Mar 13, 2017 | Merge Healthcare, Inc. Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU). Terminated |
NFJ | K110006 K913929 |
| Mar 10, 2017 | Merge Healthcare, Inc. iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare. Terminated |
LMB | K053281 |
| Mar 9, 2017 | Merge Healthcare, Inc. DR Systems Unity PACS software, now known as Merge Unity PACS Terminated |
LLZ | K041935 |
| Mar 8, 2017 | Merge Healthcare, Inc. Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K051649 |
| Mar 3, 2017 | Merge Healthcare, Inc. Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K051649 |
| Mar 2, 2017 | Merge Healthcare, Inc. 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, printin Terminated |
LLZ | K041935 |
| Feb 9, 2017 | Merge Healthcare, Inc. Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K053281 |
| Jan 23, 2017 | Merge Healthcare, Inc. Merge LIS Terminated |
NSX | None listed |
| Dec 21, 2016 | Merge Healthcare, Inc. Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K022881 |
| Dec 9, 2016 | Merge Healthcare, Inc. 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 Terminated |
HKI | K913929 |
| Dec 9, 2016 | Merge Healthcare, Inc. 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 Stat Terminated |
HKI | K913929 |
| Oct 20, 2016 | Merge Healthcare, Inc. 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 da Terminated |
LLZ | K020995 |
| Sep 2, 2016 | Merge Healthcare, Inc. Merge RadSuite software. Radiological image processing system. Terminated |
LLZ | K053281 |
| Sep 1, 2016 | Merge Healthcare, Inc. Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system. Terminated |
LLZ | K051649 |
| Aug 23, 2016 | Merge Healthcare, Inc. RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K053281 |
| Aug 4, 2016 | Merge Healthcare, Inc. Merge HEMO software. Terminated |
DQK | K082421 |
| Jul 29, 2016 | Merge Healthcare, Inc. 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 an Terminated |
LLZ | K082144 |
| Jul 14, 2016 | Merge Healthcare, Inc. 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 Terminated |
LLZ | K053281 |
| Jul 11, 2016 | Merge Healthcare, Inc. Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI. Terminated |
LLZ | K033825 |
| Jul 8, 2016 | Merge Healthcare, Inc. 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 qualif Terminated |
LLZ | K033825 |
| May 25, 2016 | Merge Healthcare, Inc. iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K092915 |
Newest 50 of 96.