510(k) K203719

IntraSight Mobile by Volcano Corporation — Product Code IYO

K203719 is an FDA 510(k) premarket notification submitted by Volcano Corporation for the device "IntraSight Mobile". The FDA issued a decision of Substantially Equivalent on January 19, 2021. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Volcano Corporation has at least 10 other 510(k) clearances on record.