MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)

About This 510(k) Submission

K252891 is an FDA 510(k) clearance for the MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2), a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Bayer Medical Care, Inc. (Indianola, US). The FDA issued a Cleared decision on February 13, 2026, 155 days after receiving the submission on September 11, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.