510(k) K242752

MRidium 3870 MRI Infusion Pump System (3870) by Iradimed Corporation — Product Code FRN

K242752 is an FDA 510(k) premarket notification submitted by Iradimed Corporation for the device "MRidium 3870 MRI Infusion Pump System (3870)". The FDA issued a decision of Substantially Equivalent on May 28, 2025. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Iradimed Corporation has at least 6 other 510(k) clearances on record.