AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS

AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS is an FDA 510(k)-cleared medical device (K081963) manufactured by Agfa Healthcare Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 24, 2008. Regulation: 8.