DIRECT DIGITIZER, REGIUS MODEL 210

DIRECT DIGITIZER, REGIUS MODEL 210 is an FDA 510(k)-cleared medical device (K092717) manufactured by Konica Minolta Medical & Graphic, 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 29, 2009. Regulation: 8.