510(k) K252689 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)
| Applicant | Imaxeon Pty, Ltd., Rydalmere, AU |
| Decision | Substantially Equivalent, Sep 24, 2025 |
| Received | Aug 26, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252689
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.