510(k) K241081 ยท OBO Tomography, Optical Coherence
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System
| Applicant | Topcon Corporation, Itabashi-Ku, JP |
| Decision | Substantially Equivalent, Jul 17, 2024 |
| Received | Apr 19, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241081
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.