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Rayence Co., Ltd.
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DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA is an FDA 510(k)-cleared medical device (K113630) manufactured by Rayence Co., 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 December 28, 2011. Regulation: 8.