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Nordicicemedical AS
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NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1 is an FDA 510(k)-cleared medical device (K063539) manufactured by Nordicicemedical AS. 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, 2007. Regulation: 8.