510(k) K252891

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) by Bayer Medical Care, Inc. — Product Code DXT

K252891 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 ISI2 Module (ISI2)". The FDA issued a decision of Substantially Equivalent on February 13, 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 at least 9 other 510(k) clearances on record.