510(k) K253770 ยท JAK System, X-Ray, Tomography, Computed
CardIQ Suite
| Applicant | GE Medical Systems SCS, Buc, FR |
| Decision | Substantially Equivalent, Jul 21, 2026 |
| Received | Nov 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253770
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.