ECHELON Oval V 5.0 MRI System

ECHELON Oval V 5.0 MRI System is an FDA 510(k)-cleared medical device (K151015) manufactured by Hitachi Medical Systems America, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 28, 2015. Regulation: 8.