K233669
- 510(k) number
- K233669
- Device name
- OEC 3D
- Applicant
- Ge Oec Medical Systems, Inc. UT · US
- Product code
- OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile
- Decision date
- 2024-03-28
- Date received
- 2023-11-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K233669.pdf
Official FDA record: K233669
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.