510(k) K252689

Device: 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.
510(k) number: K252689
Product code: IZQ
Decision: Substantially Equivalent (SESE)
Decision date: 2025-09-24
Date received: 2025-08-26
Regulation: 870.1650
Classification name: Injector, Contrast Medium, Automatic
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Anhua Hu
Address: Unit 2 38-46 S. St. Rydalmere AU 2116 2116

FDA Registration Numbers

3002807314
1000604079
3005441393
3009756327
3012529833
3011334555
8020864
3004050971
3010160527
3010173425
3006174295
1054713
1038185
3012044688
2520313
3040111919
3006791331
3002808022
9612420
1018470
3006617533
3010155661
3010659128
3002806603
3011816507
3001427085
3003366417
3030656768
9616567
3010374357
3004056159
3009882464
1518293
3004753774
2134243
3003786696
1319639
2029275

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code IZQ

510(k)	Device	Applicant	Decision date
K252281	ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)	Ulrich GmbH & Co. KG	2025-11-18
K251295	ulrichINJECT CT Motion (XD 8000)	Ulrich GmbH & Co. KG	2025-11-07
K241849	MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)	Imaxeon Pty, Ltd.	2024-11-05
K241850	ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)	Ulrich GmbH & Co. KG	2024-08-26
K233737	ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)	Ulrich GmbH & Co. KG	2024-04-19
K210541	ulrichINJECT CT motion	Ulrich GmbH & Co. KG	2021-08-06
K192872	ulrichINJECT CT Motion	Ulrich GmbH & Co. KG	2020-07-02
K171392	ulrichINJECT CT motion	Ulrich GmbH & Co. KG	2017-11-09
K151048	CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set	Bracco Injeneering	2016-01-22
K152361	OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System	Liebel-Flarsheim Company, LLC	2016-01-14
K091734	SONIC SHOT GX	Nemoto Kyorindo Co., Ltd.	2010-05-21
K063503	OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION	Mallinckrodt Inc., Liebel-Flarsheim Business	2007-04-27
K062449	EMPOWERMR INJECTOR SYSTEM, MODEL 9730	E-Z-Em, Inc.	2007-04-13
K063090	MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY	Medrad, Inc.	2007-03-27
K062265	CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM	Swiss Medical Care S.A.	2006-12-26