510(k) K253686 ยท JAK System, X-Ray, Tomography, Computed
True Definition DL
| Applicant | Ge Healthcare Japan Corporation, Hino-Shi, Tokyo, JP |
| Decision | Substantially Equivalent, Mar 23, 2026 |
| Received | Nov 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253686
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.