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Ge Medical System Israel , Ltd.
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VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K102393) manufactured by Ge Medical System Israel , Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 2010. Regulation: 8.