# Merge Healthcare Incorporated

- Location (FDA's records): Hartland, WI
- FDA decisions: 8 (2016–2025): 8 510(k) clearances
- Product codes: LLZ (6), DQK (2)
- 510(k) review time since 2016: median 56 days, against 107 for FDA's reviews in the same codes and years (6 of 8 faster)
- Predicates its devices cite: 11 (4 its own); citations of its devices by later devices: 5 (4 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ge Medical Systems Information Technologies: 1 (https://510kreport.com/company/ge-medical-systems-information-technologies)
- Emageon, Inc.: 1 (https://510kreport.com/company/emageon)
- Amicas, Inc.: 1 (https://510kreport.com/company/amicas)
- Fujifilm Medical Systems U.S.A, Inc.: 1 (https://510kreport.com/company/fujifilm-medical-systems-usa)
- Camtronics Medical Systems: 1 (https://510kreport.com/company/camtronics-medical-systems)
- Cedara Software Corp.: 1 (https://510kreport.com/company/cedara-software)
- Dr Systems, Inc.: 1 (https://510kreport.com/company/dr-systems)

## Firms that cite its devices most
- CliniComp, Intl.: 1 (https://510kreport.com/company/clinicomp-intl)

## Its most-cited devices
- K203104: IBM iConnect Access (2021), cited by 2
- K152864: Merge Hemo (2016), cited by 1
- K173475: Merge PACS (2017), cited by 1
- K182290: IBM iConnect Access (2018), cited by 1

## Recent decisions
- K250301: Merge Universal Viewer (MUV) (Apr 14, 2025)
- K233326: Merge Hemo, Model RCSV2 (Jun 21, 2024)
- K203104: IBM iConnect Access (Jan 26, 2021)
- K192455: Merge PACS (Oct 17, 2019)
- K192276: Merge Cardio (Sep 20, 2019)
- K182290: IBM iConnect Access (Sep 25, 2018)
- K173475: Merge PACS (Dec 8, 2017)
- K152864: Merge Hemo (Apr 7, 2016)

Source page: https://510kreport.com/company/merge-healthcare