DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)

DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) is an FDA 510(k)-cleared medical device (K973081) manufactured by Howtek, 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 November 4, 1997. Regulation: 8.