510(k) K110006 ยท NFJ System, Image Management, Ophthalmic
OIS SYMPHONY IMAGE MANAGMENT SYSTEM
| Applicant | Ophthalmic Imaging Systems, Sacramento CA, US |
| Decision | Substantially Equivalent, May 18, 2011 |
| Received | Jan 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110006
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2017 | Merge Healthcare, Inc. Merge Eye Care PACS Viewer 5.2
Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data.
Merge Eye Ca Terminated |
NFJ | None listed |
| Mar 13, 2017 | Merge Healthcare, Inc. Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU). Terminated |
NFJ | None listed |
| Apr 4, 2016 | Merge Healthcare, Inc. Merge Eye Station and Merge Eye Care PACS. Terminated |
NFJ | None listed |
| Mar 28, 2016 | Merge Healthcare, Inc. Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI. Terminated |
NFJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.