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GE Medical Systems
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3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL is an FDA 510(k)-cleared medical device (K003613) 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 April 2, 2001. Regulation: 8.