510(k) K192455 ยท LLZ System, Image Processing, Radiological
Merge PACS
| Applicant | Merge Healthcare Incorporated, Hartland WI, US |
| Decision | Substantially Equivalent, Oct 17, 2019 |
| Received | Sep 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192455
| 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 | None listed |
| Aug 4, 2026 | Merge Healthcare, Inc. Merge PACS, medical imaging diagnostic workstation Open, Classified |
LLZ | None listed |
| Aug 4, 2026 | Merge Healthcare, Inc. Merge OrthoPACS, medical imaging diagnostic workstation Open, Classified |
LLZ | None listed |
| Aug 6, 2020 | Merge Healthcare, Inc. Merge PACS Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.