K253269
- 510(k) number
- K253269
- Device name
- OEC One CFD
- Applicant
- Ge Hualun Medical Systems Co. , Ltd. CN
- Product code
- OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile
- Decision date
- 2025-11-26
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253269.pdf
Official FDA record: K253269
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.