ATUSA™ Automated 3D Breast Ultrasound System

ATUSA™ Automated 3D Breast Ultrasound System is an FDA 510(k)-cleared medical device (K213620) manufactured by Isono Health, 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 April 21, 2022. Regulation: 8.