510(k) K242678 ยท KPR System, X-Ray, Stationary
Definium Pace Select ET
| Applicant | Ge Hualun Medical Systems Co. , Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Oct 1, 2024 |
| Received | Sep 6, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K242678
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.