DR Systems Zero Download 3D Viewer (Z3D)

DR Systems Zero Download 3D Viewer (Z3D) is an FDA 510(k)-cleared medical device (K143318) manufactured by Dr Systems, 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 March 9, 2015. Regulation: 8.