3DHJD CAMERA SYSTEM MODEL

3DHJD CAMERA SYSTEM MODEL is an FDA 510(k)-cleared medical device (K101810) manufactured by Vision Systems Group, A Division of Viking Systems. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 29, 2010. Regulation: 8.