510(k) K253898

QT Scanner 2000 Model A by QT Imaging Holdings, Inc. — Product Code IYO

K253898 is an FDA 510(k) premarket notification submitted by QT Imaging Holdings, Inc. for the device "QT Scanner 2000 Model A". The FDA issued a decision of Substantially Equivalent on March 4, 2026. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560.