Orthoscan TAU Mini C-Arm

Orthoscan TAU Mini C-Arm is an FDA 510(k)-cleared medical device (K250587) 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 July 1, 2025. Regulation: 8.