KONICA DIRECT DIGITIZER, MODEL DD-341

KONICA DIRECT DIGITIZER, MODEL DD-341 is an FDA 510(k)-cleared medical device (K990359) 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 August 16, 1999. Regulation: 8.