AI Platform 2.2 (AIP002)

AI Platform 2.2 (AIP002) is an FDA 510(k)-cleared medical device (K260217) manufactured by Exo Imaging. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 23, 2026. Regulation: 8.