510(k) K173475 ยท LLZ System, Image Processing, Radiological
Merge PACS
| Applicant | Merge Healthcare Incorporated, Hartland WI, US |
| Decision | Substantially Equivalent, Dec 8, 2017 |
| Received | Nov 9, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173475
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2019 | Merge Healthcare, Inc. Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 Terminated |
LLZ | None listed |
| Jul 11, 2019 | Merge Healthcare, Inc. Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1 Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.