510(k) K121739 ยท HLI Ophthalmoscope, Ac-Powered
IVUE WITH NORMATIVE DATABASE
| Applicant | Optovue, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Jan 18, 2013 |
| Received | Jun 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121739
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2017 | Optovue, Inc. iVue with Normative Database, Device Listing Number D185549.
Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axi Terminated |
HLI | None listed |
| Mar 16, 2016 | Optovue, Inc. iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US)
Opthalmic: iVue is a non-contact, high resolution tomographic imaging dev Terminated |
HLI | None listed |
| May 31, 2013 | Optovue, Inc. Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1.
Intended for in vivo imaging. Terminated |
HLI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.