K251004 is an FDA 510(k) clearance for the Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M). This device is classified as a Image-intensified Fluoroscopic X-ray System, Mobile (Class II - Special Controls, product code OXO).
Submitted by Hefei Chimed Intelligent Machine Co., Ltd. (Hefei, CN). The FDA issued a Cleared decision on November 6, 2025, 219 days after receiving the submission on April 1, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Fluoroscopy Of The Human Body..
| 510(k) Number | K251004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2025 |
| Decision Date | November 06, 2025 |
| Days to Decision | 219 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OXO - Image-intensified Fluoroscopic X-ray System, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Fluoroscopy Of The Human Body. |