510(k) K182213

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

K182213 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 Sep 14, 2018. 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.