Automated Aortic Stenosis Software (AutoAS)

Automated Aortic Stenosis Software (AutoAS) is an FDA 510(k)-cleared medical device (K254161) manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 26, 2026. Regulation: 8.