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Dxrad Solutions , Ltd.
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DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS is an FDA 510(k)-cleared medical device (K082261) manufactured by Dxrad Solutions , Ltd.. 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 5, 2008. Regulation: 8.