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General Electric Co.
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GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM is an FDA 510(k)-cleared medical device (K043112) 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 November 23, 2004. Regulation: 8.