MammoSightAI

MammoSightAI is an FDA 510(k)-cleared medical device (K252954) manufactured by Neurocareai, Inc. (Dba Savelife.Ai). This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 3, 2026. Regulation: 8.