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Invivo Corporation
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MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS is an FDA 510(k)-cleared medical device (K053017) manufactured by Invivo Corporation. 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 15, 2005. Regulation: 8.