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Minxray, Inc.
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MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL is an FDA 510(k)-cleared medical device (K082627) manufactured by Minxray, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 6, 2008. Regulation: 8.