K241567
- 510(k) number
- K241567
- Device name
- MC2 Portable X-ray System
- Applicant
- Oxos Medical GA · US
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2024-12-06
- Date received
- 2024-05-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241567.pdf
Official FDA record: K241567
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.