MRidium 3860+ MRI infusion Pump/ Monitoring System

MRidium 3860+ MRI infusion Pump/ Monitoring System is an FDA 510(k)-cleared medical device (K143369) manufactured by Iradimed Corporation. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 14, 2016. Regulation: 8.