510(k) K251004 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
| Applicant | Hefei Chimed Intelligent Machine Co., Ltd., Hefei, CN |
| Decision | Substantially Equivalent, Nov 6, 2025 |
| Received | Apr 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251004
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.