AI-Rad Companion (Cardiovascular)

AI-Rad Companion (Cardiovascular) is an FDA 510(k)-cleared medical device (K222360) manufactured by Siemens Medical Solutions U.S.A.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 5, 2023. Regulation: 8.