AI Platform 2.0 (AIP002)

AI Platform 2.0 (AIP002) is an FDA 510(k)-cleared medical device (K240953) 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 August 4, 2024. Regulation: 8.