HYDRA VISION UROLOGICAL X-RAY SYSTEM

HYDRA VISION UROLOGICAL X-RAY SYSTEM is an FDA 510(k)-cleared medical device (K904145) manufactured by Mallinckrodt Group, 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 December 12, 1990. Regulation: 8.