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Toshiba Medical Systems Corporation, Japan
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INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V is an FDA 510(k)-cleared medical device (K112054) manufactured by Toshiba Medical Systems Corporation, Japan. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 4, 2011. Regulation: 8.