510(k) K110869 ยท NFJ System, Image Management, Ophthalmic
CARA
| Applicant | Diagnos, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Jul 14, 2011 |
| Received | Mar 29, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110869
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2022 | Diagnos Inc CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 Terminated |
NFJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.