510(k) K173860

s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System by Volcano Corporation — Product Code IYO

K173860 is an FDA 510(k) premarket notification submitted by Volcano Corporation for the device "s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System". The FDA issued a decision of Substantially Equivalent on April 11, 2018. 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.