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Alpinion Medical Systems Co., Ltd.
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E-CUBE 9 is an FDA 510(k)-cleared medical device (K111864) manufactured by Alpinion Medical Systems 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 July 14, 2011. Regulation: 8.