510(k) K173612 ยท KPR System, X-Ray, Stationary
Optima XR646 HD
| Applicant | Ge Hualun Medical Systems Co. , Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Dec 11, 2017 |
| Received | Nov 22, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K173612
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2025 | GE Medical Systems, LLC Optima XR646 HD. 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.