K250587
- 510(k) number
- K250587
- Device name
- Orthoscan TAU Mini C-Arm
- Applicant
- Ziehm-Orthoscan, Inc. AZ · US
- Product code
- OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile
- Decision date
- 2025-07-02
- Date received
- 2025-02-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250587.pdf
Official FDA record: K250587
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.