510(k) K982689 ยท HKI Camera, Ophthalmic, Ac-Powered
WINSTATION RETINAL IMAGER
| Applicant | Ophthalmic Imaging Systems, Sacramento CA, US |
| Decision | Substantially Equivalent, Oct 23, 1998 |
| Received | Aug 3, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982689
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2019 | Merge Healthcare, Inc. The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System
Product Usage:
The WinStation Retinal Imager has the same intended use as other fundus camera Terminated |
HKI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.