510(k) K153369

SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz by Volcano Corporation — Product Code IYO

K153369 is an FDA 510(k) premarket notification submitted by Volcano Corporation for the device "SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz". The FDA issued a decision of Substantially Equivalent on December 22, 2015. 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.