AI-Rad Companion (Pulmonary)

AI-Rad Companion (Pulmonary) is an FDA 510(k)-cleared medical device (K183271) 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 25, 2019. Regulation: 8.