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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 K262043
Device Name MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike
Applicant
Bayer Medical Care, Inc.
1 Bayer Dr.
Indianola,  PA  15051
Applicant Contact Troy Jack
Correspondent
Bayer Medical Care, Inc.
1 Bayer Dr.
Indianola,  PA  15051
Correspondent Contact Nishanth Reddy Deva
Regulation Number870.1650
Classification Product Code
DXT  
Subsequent Product Code
PQH  
Date Received06/17/2026
Decision Date 10/06/2026
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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