Orthoscan VERSA Mini C-Arm

Orthoscan VERSA Mini C-Arm is an FDA 510(k)-cleared medical device (K243452) manufactured by Ziehm-Orthoscan, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 13, 2025. Regulation: 8.