510(k) K233583 ยท JAK System, X-Ray, Tomography, Computed
FCT iSTREAM Phase 1
| Applicant | FUJIFILM Healthcare Americas Corporation, Lexington MA, US |
| Decision | Substantially Equivalent, Apr 26, 2024 |
| Received | Nov 7, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233583
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.