K240828
- 510(k) number
- K240828
- Device name
- OEC One ASD
- Applicant
- Ge Hualun Medical Systems Co. , Ltd. CN
- Product code
- OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile
- Decision date
- 2024-12-27
- Date received
- 2024-03-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K240828.pdf
Official FDA record: K240828
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.