510(k) Report

FDA applicant

Merge Healthcare Incorporated

Hartland, WI8 decisions2016–20259 recalls

FDA records 8 decisions for Merge Healthcare Incorporated (Hartland, WI) from 2016 to 2025: 8 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and DQK (Computer, Diagnostic, Programmable). Since 2016 its 510(k)s took a median of 56 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 4 of them its own earlier devices. 9 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Merge Healthcare Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016: 12017: 12018: 12019: 22021: 12024: 12025: 1
2016high 2 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

3in 2026

2017: 12019: 22020: 12021: 12025: 12026 (partial year): 3
2016high 3 (2026) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Merge Healthcare Incorporated by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological6decisions
  • DQKComputer, Diagnostic, Programmable2decisions

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 56 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 6 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K203104IBM iConnect AccessMerge Healthcare Incorporated · 20212cite it
  • K152864Merge HemoMerge Healthcare Incorporated · 20161cites it
  • K173475Merge PACSMerge Healthcare Incorporated · 20171cites it
  • K182290IBM iConnect AccessMerge Healthcare Incorporated · 20181cites it

What has FDA decided for it lately?

  • K250301Merge Universal Viewer (MUV)Merge Healthcare Incorporated · 2025
  • K233326Merge Hemo, Model RCSV2Merge Healthcare Incorporated · 20241 recall
  • K203104IBM iConnect AccessMerge Healthcare Incorporated · 2021
  • K192455Merge PACSMerge Healthcare Incorporated · 20194 recalls
  • K192276Merge CardioMerge Healthcare Incorporated · 2019
  • K182290IBM iConnect AccessMerge Healthcare Incorporated · 2018
  • K173475Merge PACSMerge Healthcare Incorporated · 20172 recalls
  • K152864Merge HemoMerge Healthcare Incorporated · 20162 recalls

All 8 as Merge Healthcare Incorporated →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K192455Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstationJul 22, 2026Class II
  • K192455Merge PACS, medical imaging diagnostic workstationJun 30, 2026Class II
  • K192455Merge OrthoPACS, medical imaging diagnostic workstationJun 30, 2026Class II
  • K233326Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and…Aug 11, 2025Class II
  • K152864Merge Hemo, Software packages 10.2, 10.3, and 10.4Jul 23, 2021Class II
  • K192455Merge PACSAug 6, 2020Class II

Other applicant names beginning “Merge”

FDA records each applicant name separately; these may or may not be the same firm.

Merge Technologies, Inc. 1