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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Contrast Medium, Automatic
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.
Unit 2
38-46 S. St.
Rydalmere,  AU 2116
Applicant Contact Anhua Hu
Correspondent
Bayer Medical Care, Inc.
1 Bayer Dr.
Indianola,  PA  15051
Correspondent Contact Gopal Abbineni
Regulation Number870.1650
Classification Product Code
IZQ  
Date Received08/26/2025
Decision Date 09/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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