510(k) K151048

CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set by Bracco Injeneering — Product Code IZQ

K151048 is an FDA 510(k) premarket notification submitted by Bracco Injeneering for the device "CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set". The FDA issued a decision of Substantially Equivalent on January 22, 2016. The device falls under product code IZQ (Injector, Contrast Medium, Automatic), a Class II device regulated under 21 CFR 870.1650. Bracco Injeneering has at least 1 other 510(k) clearance on record.