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Electronic Business Machine Co., Ltd. (Ebm)
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UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0 is an FDA 510(k)-cleared medical device (K062743) manufactured by Electronic Business Machine Co., Ltd. (Ebm). This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 30, 2006. Regulation: 8.