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Quality Electrodynamics
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TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL is an FDA 510(k)-cleared medical device (K091114) manufactured by Quality Electrodynamics. 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 30, 2009. Regulation: 8.