510(k) K143538

MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit by Bayer Medical Care, Inc. — Product Code DXT

K143538 is an FDA 510(k) premarket notification submitted by Bayer Medical Care, Inc. for the device "MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit". The FDA issued a decision of Substantially Equivalent on August 14, 2015. 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.