510(k) K254189 ยท QIH Automated Radiological Image Processing Software
Synapse 3D Base Tools (V7.2)
| Applicant | Fujifilm Corporation, Minato-Ku, Tokyo, JP |
| Decision | Substantially Equivalent, Apr 30, 2026 |
| Received | Dec 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254189
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.