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Acrorad Co., Ltd.
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MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U is an FDA 510(k)-cleared medical device (K043293) manufactured by Acrorad 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 16, 2004. Regulation: 8.