Trillium Oval V 5.1 MRI System

Trillium Oval V 5.1 MRI System is an FDA 510(k)-cleared medical device (K160152) 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 May 19, 2016. Regulation: 8.