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Neusoft Medical Systems Co., Ltd.
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NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM is an FDA 510(k)-cleared medical device (K121792) manufactured by Neusoft 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 November 15, 2012. Regulation: 8.