KONICA DIRECT DIGITIZER KD-1000

KONICA DIRECT DIGITIZER KD-1000 is an FDA 510(k)-cleared medical device (K920558) manufactured by Konica Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 5, 1992. Regulation: 8.