510(k) K253893 ยท NFJ System, Image Management, Ophthalmic
Harmony Referral System with Harmony OCT Viewer (Octave)
| Applicant | Topcon Healthcare Solutions EMEA Oy, Oulu, FI |
| Decision | Substantially Equivalent, Jun 4, 2026 |
| Received | Dec 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253893
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.