
Quality Electrodynamics
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SPEEDER 1.5T WRIST ARRAY COIL is an FDA 510(k)-cleared medical device (K072935) 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 October 30, 2007. Regulation: 8.