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Ge Medical Systems, LLC
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GE SIGNA PROFILE 6 INCH GP COIL is an FDA 510(k)-cleared medical device (K041921) manufactured by 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 July 25, 2004. Regulation: 8.