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Agfa Healthcare N.V.
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CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER is an FDA 510(k)-cleared medical device (K111324) manufactured by Agfa Healthcare N.V.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 2011. Regulation: 8.