510(k) K231892 ยท KPR System, X-Ray, Stationary
Definium Pace Select
| Applicant | Ge Hualun Medical Systems Co. , Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Sep 12, 2023 |
| Received | Jun 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231892
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2025 | GE Medical Systems, LLC Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system. Open, Classified |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.