510(k) K031571

EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 by E-Z-Em, Inc. — Product Code IZQ

K031571 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825". The FDA issued a decision of Substantially Equivalent on June 19, 2003. The device falls under product code IZQ (Injector, Contrast Medium, Automatic), a Class II device regulated under 21 CFR 870.1650. E-Z-Em, Inc. has at least 10 other 510(k) clearances on record.