MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit is an FDA 510(k)-cleared medical device (K182276) manufactured by Bayer Medical Care, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 31, 2018. Regulation: 8.