Genius AI Detection 2.0 with CC-MLO Correlation

Genius AI Detection 2.0 with CC-MLO Correlation is an FDA 510(k)-cleared medical device (K230096) manufactured by Hologic, Inc.. 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 22, 2023. Regulation: 8.