510(k) K250791

ASUS Ultrasound Imaging System (LU800 series) by Asustek Computer, Inc. — Product Code IYN

K250791 is an FDA 510(k) premarket notification submitted by Asustek Computer, Inc. for the device "ASUS Ultrasound Imaging System (LU800 series)". The FDA issued a decision of Substantially Equivalent on Dec 4, 2025. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550.