
Ge Medical Systems Israel, Ultrasound, Ltd.
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MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND is an FDA 510(k)-cleared medical device (K092079) manufactured by Ge Medical Systems Israel, Ultrasound, 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 August 5, 2009. Regulation: 8.