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Philips Medical Systems North America, Inc.
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TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T is an FDA 510(k)-cleared medical device (K013894) manufactured by Philips Medical Systems North America, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 17, 2002. Regulation: 8.