510(k) K180019

CAAS Workstation by Pie Medical Imaging BV — Product Code IZI

K180019 is an FDA 510(k) premarket notification submitted by Pie Medical Imaging BV for the device "CAAS Workstation". The FDA issued a decision of Substantially Equivalent on May 3, 2018. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Pie Medical Imaging BV has at least 10 other 510(k) clearances on record.