Merge Healthcare Incorporated: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Merge Healthcare Incorporated” (first 2016, latest 2025), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 56 days. Since 2017 the median was 38 days, against 125 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 190 |
| 2017 | 1 | 29 |
| 2018 | 1 | 33 |
| 2019 | 2 | 34 |
| 2020 | 0 | — |
| 2021 | 1 | 104 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 266 |
| 2025 | 1 | 73 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Merge Healthcare Incorporated took a median 38 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 6 | 6 |
| DQK | Computer, Diagnostic, Programmable | 2 | 2 |
Review panels
- Radiology (6)
- Cardiovascular (2)
Most recent Merge Healthcare Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250301 | Merge Universal Viewer (MUV) | LLZ | 2025-04-14 | 73 |
| K233326 | Merge Hemo, Model RCSV2 | DQK | 2024-06-21 | 266 |
| K203104 | IBM iConnect Access | LLZ | 2021-01-26 | 104 |
| K192455 | Merge PACS | LLZ | 2019-10-17 | 38 |
| K192276 | Merge Cardio | LLZ | 2019-09-20 | 29 |
| K182290 | IBM iConnect Access | LLZ | 2018-09-25 | 33 |
| K173475 | Merge PACS | LLZ | 2017-12-08 | 29 |
| K152864 | Merge Hemo | DQK | 2016-04-07 | 190 |
Recalls
openFDA lists no recalls under a recalling firm named Merge Healthcare Incorporated.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Merge Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Merge Healthcare Incorporated?
FDA lists 8 510(k) clearances under the applicant name “Merge Healthcare Incorporated” (first 2016, latest 2025), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Merge Healthcare Incorporated?
The median time from FDA receipt to decision across 510(k)s cleared under the name Merge Healthcare Incorporated is 56 days. Since 2017: 38 days, versus 125 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Merge Healthcare Incorporated?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 6); DQK (Computer, Diagnostic, Programmable, 2).
Next steps
- See all 8 Merge Healthcare Incorporated clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Merge Healthcare Incorporated's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.