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Ge Healthcare (Ge Medical Systems, LLC)
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OPTIMA MR450W is an FDA 510(k)-cleared medical device (K123522) manufactured by Ge Healthcare (Ge Medical Systems, LLC). This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 12, 2013. Regulation: 8.