AI-Rad Companion Prostate MR

AI-Rad Companion Prostate MR is an FDA 510(k)-cleared medical device (K193283) 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 July 29, 2020. Regulation: 8.