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Toshiba Medical Systems Corporation, Japan
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APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K103645) 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 January 11, 2011. Regulation: 8.