510(k) K984058

ACIST INJECTOR SYSTEM, MODEL CL100 H by Acist Medical Systems — Product Code IZQ

K984058 is an FDA 510(k) premarket notification submitted by Acist Medical Systems for the device "ACIST INJECTOR SYSTEM, MODEL CL100 H". The FDA issued a decision of Substantially Equivalent on February 11, 1999. The device falls under product code IZQ (Injector, Contrast Medium, Automatic), a Class II device regulated under 21 CFR 870.1650. Acist Medical Systems has at least 10 other 510(k) clearances on record.