510(k) K253269 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
OEC One CFD
| Applicant | Ge Hualun Medical Systems Co. , Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Nov 26, 2025 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253269
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.