HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE

HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE is an FDA 510(k)-cleared medical device (K913264) 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 October 31, 1991. Regulation: 8.