Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003786696

FEI Number

3003786696

Entity Name

IMAXEON PTY LTD

City/State/Country

Rydalmere New South Wales, AU

Establishment Address

Unit 1, 38-46 South Street, Rydalmere New South Wales 2116, AU

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Imaxeon Pty Ltd (Owner Number: 10092112)

Owner / Operator Contact Address

1 Bayer Drive, Indianola, PA 15051, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252689

PMA Number

N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2024-12-05
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2024-12-05
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2026-04-23

Official Correspondent

Anhua Hu

US Agent Details

Troy Jack Email: troy.jack@bayer.com Phone: (412) 3528280

Related Public Records

Same Entity

Imaxeon Pty Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003786696. Last updated year: 2026. Please use registration number 3003786696 when referencing this establishment in official correspondence.