510(k) K133993

CAAS WORKSTATION by Pie Medical Imaging — Product Code IZI

K133993 is an FDA 510(k) premarket notification submitted by Pie Medical Imaging for the device "CAAS WORKSTATION". The FDA issued a decision of Substantially Equivalent on March 25, 2014. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Pie Medical Imaging has at least 10 other 510(k) clearances on record.