510(k) K062449

EMPOWERMR INJECTOR SYSTEM, MODEL 9730 by E-Z-Em, Inc. — Product Code IZQ

K062449 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "EMPOWERMR INJECTOR SYSTEM, MODEL 9730". The FDA issued a decision of Substantially Equivalent on April 13, 2007. 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.