510(k) K912944

CT 8000 DIGITAL INJECTION SYSTEM by Mallinckrodt Group, Inc. — Product Code DXT

K912944 is an FDA 510(k) premarket notification submitted by Mallinckrodt Group, Inc. for the device "CT 8000 DIGITAL INJECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 4, 1992. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Mallinckrodt Group, Inc. has at least 10 other 510(k) clearances on record.