MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)

About This 510(k) Submission

K252689 is an FDA 510(k) clearance for the MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2), a Injector, Contrast Medium, Automatic (Class II — Special Controls, product code IZQ), submitted by Imaxeon Pty, Ltd. (Rydalmere, AU). The FDA issued a Cleared decision on September 24, 2025, 29 days after receiving the submission on August 26, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.