510(k) K250381

Deepsight NeedleVue LC1 Ultrasound System by DeepSight Technology, Inc. — Product Code IYO

K250381 is an FDA 510(k) premarket notification submitted by DeepSight Technology, Inc. for the device "Deepsight NeedleVue LC1 Ultrasound System". The FDA issued a decision of Substantially Equivalent on August 1, 2025. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560.