510(k) K171370 ยท NFJ System, Image Management, Ophthalmic
IMAGEnet 6 Ophthalmic Data System
| Applicant | Topcon Corporation, Tokyo, JP |
| Decision | Substantially Equivalent, Nov 1, 2017 |
| Received | May 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171370
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2019 | Topcon Medical Systems, Inc. IMAGEnet 6 v1.53-
IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clini Terminated |
NFJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.