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General Electric Co.
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GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION is an FDA 510(k)-cleared medical device (K082317) manufactured by General Electric Co.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 25, 2008. Regulation: 8.