510(k) K063090

MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY by Medrad, Inc. — Product Code IZQ

K063090 is an FDA 510(k) premarket notification submitted by Medrad, Inc. for the device "MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY". The FDA issued a decision of Substantially Equivalent on March 27, 2007. The device falls under product code IZQ (Injector, Contrast Medium, Automatic), a Class II device regulated under 21 CFR 870.1650. Medrad, Inc. has at least 10 other 510(k) clearances on record.