510(k) K063503

OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION by Mallinckrodt Inc., Liebel-Flarsheim Business — Product Code IZQ

K063503 is an FDA 510(k) premarket notification submitted by Mallinckrodt Inc., Liebel-Flarsheim Business for the device "OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION". The FDA issued a decision of Substantially Equivalent on April 27, 2007. The device falls under product code IZQ (Injector, Contrast Medium, Automatic), a Class II device regulated under 21 CFR 870.1650. Mallinckrodt Inc., Liebel-Flarsheim Business has at least 7 other 510(k) clearances on record.