510(k) K262043

MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike by Bayer Medical Care, Inc. — Product Code DXT

K262043 is an FDA 510(k) premarket notification submitted by Bayer Medical Care, Inc. for the device "MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike". The FDA issued a decision of Substantially Equivalent on Oct 6, 2026. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Bayer Medical Care, Inc. has 10 other 510(k) clearances on record.