510(k) K252689— MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)

Substantially Equivalent

Imaxeon Pty, Ltd.

Clearance details

Applicant: Imaxeon Pty, Ltd.
Product code: Code IZQ
Advisory panel: Cardiovascular
Date received: 2025-08-26
Decision date: 2025-09-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Rydalmere, AU

Adverse events under product code IZQ

product code IZQ

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.