K251004
- 510(k) number
- K251004
- Device name
- Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
- Applicant
- Hefei Chimed Intelligent Machine Co., Ltd. CN
- Product code
- OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile
- Decision date
- 2025-11-06
- Date received
- 2025-04-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.4 MB · U.S. public domain
Also available from FDA: K251004.pdf
Official FDA record: K251004
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.