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Digimed Corporation
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PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX is an FDA 510(k)-cleared medical device (K082167) manufactured by Digimed Corporation. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 25, 2008. Regulation: 8.