MRIdian Linac System with 138-leaf Collimator

MRIdian Linac System with 138-leaf Collimator is an FDA 510(k)-cleared medical device (K170751) manufactured by Viewray, Incorporated. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 6, 2017. Regulation: 8.