K252689

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

510(k) number: K252689
Device name: 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. AU
Product code: IZQ — Injector, Contrast Medium, Automatic
Decision date: 2025-09-24
Date received: 2025-08-26
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: Cardiovascular

PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain

Also available from FDA: K252689.pdf

Official FDA record: K252689

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.