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Invivo
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1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484 is an FDA 510(k)-cleared medical device (K091902) manufactured by Invivo. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 20, 2009. Regulation: 8.