Clearance Summary
Orthoscan VERSA Mini C-Arm received FDA 510(k) clearance under submission number K243452, sponsored by Ziehm-Orthoscan, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-01-14.
- Submission: K243452
- Applicant / Sponsor: Ziehm-Orthoscan, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2025-01-14
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.