i-CAT FLX V series / KaVo 3D eXam+ V series

i-CAT FLX V series / KaVo 3D eXam+ V series is an FDA 510(k)-cleared medical device (K162085) 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 November 9, 2016. Regulation: 8.