TxRx Knee 15 Flare MR Coil 3.0T

TxRx Knee 15 Flare MR Coil 3.0T is an FDA 510(k)-cleared medical device (K163066) manufactured by Quality Electrodynamics, LLC. 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 28, 2016. Regulation: 8.