510(k) K133892 ยท HLI Ophthalmoscope, Ac-Powered
IVUE 500
| Applicant | Optovue, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Mar 19, 2014 |
| Received | Dec 20, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133892
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2017 | Optovue, Inc. iVue 500 with iScan, D216606.
Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measureme 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.