
Ge Medical System Israel , Ltd.
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VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K121062) 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 August 16, 2012. Regulation: 8.