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Canon USA, Inc.
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CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 is an FDA 510(k)-cleared medical device (K003689) manufactured by Canon USA, 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 January 1, 2002. Regulation: 8.