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GE Medical Systems
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GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM is an FDA 510(k)-cleared medical device (K053009) manufactured by GE Medical Systems. 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 16, 2005. Regulation: 8.