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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K252891
Device Name MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
Applicant
Bayer Medical Care, Inc.
1 Bayer Dr.
Indianola,  PA  15051 -0780
Applicant Contact Troy Jack
Correspondent
Bayer Medical Care, Inc.
1 Bayer Dr.
Indianola,  PA  15051 -0780
Correspondent Contact Colleen Witt
Regulation Number870.1650
Classification Product Code
DXT  
Date Received09/11/2025
Decision Date 02/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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