AI-Rad Companion (Pulmonary)

AI-Rad Companion (Pulmonary) is an FDA 510(k)-cleared medical device (K213713) manufactured by Siemens Healthcare GmbH. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 10, 2022. Regulation: 8.