RevealAI-Lung

RevealAI-Lung is an FDA 510(k)-cleared medical device (K251769) manufactured by Precision Medical Ventures, Inc. Dba Revealdx. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 29, 2026. Regulation: 8.