QT Ultrasound Breast Scanner - 1

QT Ultrasound Breast Scanner - 1 is an FDA 510(k)-cleared medical device (K182213) manufactured by Qt Ultrasound, 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 September 13, 2018. Regulation: 8.