510(k) K152361

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System by Liebel-Flarsheim Company, LLC — Product Code IZQ

K152361 is an FDA 510(k) premarket notification submitted by Liebel-Flarsheim Company, LLC for the device "OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System". The FDA issued a decision of Substantially Equivalent on January 14, 2016. The device falls under product code IZQ (Injector, Contrast Medium, Automatic), a Class II device regulated under 21 CFR 870.1650. Liebel-Flarsheim Company, LLC has at least 1 other 510(k) clearance on record.