IRadimed submits 510(k) at FDA request

MRI accessories company IRadimed has submitted a 510(k) application to the U.S Food and Drug Administration (FDA) for its MRidium 3860+ MRI IV infusion pump.

In September, the FDA issued a warning letter to IRadimed, requesting that it stop commercial distribution of its MRI IV infusion pumps and submit a 510(k) application. IRadimed President and CEO Roger Susi said the company is prepared to resume shipments once it receives FDA clearance.