510(k) K250788 ยท KPR System, X-Ray, Stationary
Definium Tempo Select
| Applicant | Ge Hualun Medical Systems Co. , Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Aug 28, 2025 |
| Received | Mar 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250788
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.