AI-Rad Companion (Musculoskeletal)

AI-Rad Companion (Musculoskeletal) is an FDA 510(k)-cleared medical device (K222361) manufactured by Siemens Medical Solutions USA, 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 October 19, 2022. Regulation: 8.