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Ge Medical Systems Ultrasound and Primary Care Dia
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GE LUNAR VISCERAL FAT SOFTWARE is an FDA 510(k)-cleared medical device (K103730) manufactured by Ge Medical Systems Ultrasound and Primary Care Dia. 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 5, 2011. Regulation: 8.