Clearance Summary
Orthoscan TAU Mini C-Arm received FDA 510(k) clearance under submission number K250587, sponsored by Ziehm-Orthoscan, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-07-02.
- Submission: K250587
- Applicant / Sponsor: Ziehm-Orthoscan, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2025-07-02
Classification & Regulation
This clearance is catalogued under FDA product code OXO and 21 CFR 892.1650, within the Radiology review panel as a Class II device.