ACCUSYTE 3D Fiducial Marker

ACCUSYTE 3D Fiducial Marker is an FDA 510(k)-cleared medical device (K180027) manufactured by Radiation Products, LLC. 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 17, 2018. Regulation: 8.