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Shimadzu Medical Systems
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ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO is an FDA 510(k)-cleared medical device (K061643) manufactured by Shimadzu Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 26, 2006. Regulation: 8.