510(k) K913929 ยท HKI Camera, Ophthalmic, Ac-Powered
DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM
| Applicant | Ophthalmic Imaging Systems, Sacramento CA, US |
| Decision | Substantially Equivalent, Nov 27, 1991 |
| Received | Sep 3, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913929
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Dec 9, 2016 | Merge Healthcare, Inc. Merge Eye Station.
f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS).
Model number 136 T1700 Capture Stat Terminated |
HKI | None listed |
| Dec 9, 2016 | Merge Healthcare, Inc. Merge Eye Station
f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior Terminated |
HKI | 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.