510(k) K252689

MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) by Imaxeon Pty, Ltd. — Product Code IZQ

K252689 is an FDA 510(k) premarket notification submitted by Imaxeon Pty, Ltd. for the device "MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)". The FDA issued a decision of Substantially Equivalent on September 24, 2025. The device falls under product code IZQ (Injector, Contrast Medium, Automatic), a Class II device regulated under 21 CFR 870.1650. Imaxeon Pty, Ltd. has at least 1 other 510(k) clearance on record.