CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM

CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K133620) manufactured by Imaging Sciences International. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 13, 2014. Regulation: 8.