The ViewRay (MRIdian) Linac System

The ViewRay (MRIdian) Linac System is an FDA 510(k)-cleared medical device (K162393) 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 February 23, 2017. Regulation: 8.