TRILLIUM Oval Head Coil 32

TRILLIUM Oval Head Coil 32 is an FDA 510(k)-cleared medical device (K162079) 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 September 15, 2016. Regulation: 8.