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Barco N.V.
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COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM is an FDA 510(k)-cleared medical device (K040365) manufactured by Barco 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 April 27, 2004. Regulation: 8.