510(k) K243132

Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Product Code IYN

K243132 is an FDA 510(k) premarket notification submitted by Shantou Institute of Ultrasonic Instruments Co., Ltd. for the device "Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)". The FDA issued a decision of Substantially Equivalent on December 10, 2024. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Shantou Institute of Ultrasonic Instruments Co., Ltd. has at least 2 other 510(k) clearances on record.