510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K241849Substantially Equivalent

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

Imaxeon Pty Ltd, Rydalmere, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K241849 is the FDA 510(k) clearance record for MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2), a class II device, cleared for Imaxeon Pty, Ltd. on under FDA product code IZQ (Injector, Contrast Medium, Automatic). FDA records list 2 510(k) clearances for Imaxeon Pty, Ltd., from to . As of , FDA records show no recalls naming K241849.

Clearance record

Decision date
Received
(131 days to decision)
Product code
IZQ Injector, Contrast Medium, Automatic
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Imaxeon Pty, Ltd. Unit 2, Rydalmere, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IZQ

Trailing 12 months
3 clearances under product code IZQ in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IZQ, trailing twelve months
MonthClearances
November 20252
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260