
Shantou Institute of Ultrasonic Instuments
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SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K081110) manufactured by Shantou Institute of Ultrasonic Instuments. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 15, 2008. Regulation: 8.