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Agfa Corporation
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COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION is an FDA 510(k)-cleared medical device (K053634) manufactured by Agfa 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 January 16, 2006. Regulation: 8.