QT Ultrasound Breast Scanner-1

QT Ultrasound Breast Scanner-1 is an FDA 510(k)-cleared medical device (K162372) 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 June 5, 2017. Regulation: 8.