PCCR DIGITAL IMAGING DEVICE

PCCR DIGITAL IMAGING DEVICE is an FDA 510(k)-cleared medical device (K003256) manufactured by Orex Computed Radiography, Ltd.. 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 7, 2000. Regulation: 8.