ClearanceBrief
510(k) K241849 ยท IZQ Injector, Contrast Medium, Automatic

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

ApplicantImaxeon Pty, Ltd., Rydalmere, AU
DecisionSubstantially Equivalent, Nov 5, 2024
ReceivedJun 27, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K241849

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.