510(k) K162372

QT Ultrasound Breast Scanner-1 by Qt Ultrasound, LLC — Product Code IYO

K162372 is an FDA 510(k) premarket notification submitted by Qt Ultrasound, LLC for the device "QT Ultrasound Breast Scanner-1". The FDA issued a decision of Substantially Equivalent on Jun 6, 2017. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Qt Ultrasound, LLC has 2 other 510(k) clearances on record.