510(k) K232828 ยท NFJ System, Image Management, Ophthalmic
IMAGEnet6 Ophthalmic Data System
| Applicant | Topcon Corporation, Itabashi-Ku, JP |
| Decision | Substantially Equivalent, Mar 1, 2024 |
| Received | Sep 13, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232828
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2024 | Topcon Medical Systems, Inc. The 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 clinical information Open, Classified |
NFJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.