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Toshiba America Medical Systems, In.C
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DRAD3000E/RADREX-I is an FDA 510(k)-cleared medical device (K082494) manufactured by Toshiba America Medical Systems, In.C. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 11, 2008. Regulation: 8.