510(k) K241554

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) by Telefield Medical Imaging (Shenzhen) Limited — Product Code IYN

K241554 is an FDA 510(k) premarket notification submitted by Telefield Medical Imaging (Shenzhen) Limited for the device "Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)". The FDA issued a decision of Substantially Equivalent on October 24, 2024. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550.