510(k) K253836 ยท JAK System, X-Ray, Tomography, Computed
FCT iStream Phase 2
| Applicant | Fujifilm Corporation, Minato-Ku, JP |
| Decision | Substantially Equivalent, Sep 4, 2026 |
| Received | Dec 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253836
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.