K252579
- 510(k) number
- K252579
- Device name
- Orthoscan TAU MVP Mini C-Arm System
- Applicant
- Ziehm-Orthoscan, Inc. AZ · US
- Product code
- OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile
- Decision date
- 2026-01-14
- Date received
- 2025-08-15
- 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: K252579.pdf
Official FDA record: K252579
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.