510(k) K091404 ยท OBO Tomography, Optical Coherence
IVUE, MODEL 100
| Applicant | Optovue, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Apr 22, 2010 |
| Received | May 12, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091404
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2012 | Optovue Inc. Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: Terminated |
OBO | None listed |
| Feb 1, 2011 | Optovue Inc. Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA
Computer controlled opthalmic imaging system. Device scans the pat Terminated |
NQQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.