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Aloka Co. Ltd USA
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ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K032875) manufactured by Aloka Co. Ltd USA. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 29, 2003. Regulation: 8.