KONICA DIRECT DIGITIZER REGIUS MODEL 330

KONICA DIRECT DIGITIZER REGIUS MODEL 330 is an FDA 510(k)-cleared medical device (K980873) 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 June 18, 1998. Regulation: 8.