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Choong Wae Medical Corp.
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DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D is an FDA 510(k)-cleared medical device (K083640) manufactured by Choong Wae Medical Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 28, 2009. Regulation: 8.