510(k) K163066

TxRx Knee 15 Flare MR Coil 3.0T by Quality Electrodynamics, LLC — Product Code MOS

K163066 is an FDA 510(k) premarket notification submitted by Quality Electrodynamics, LLC for the device "TxRx Knee 15 Flare MR Coil 3.0T". The FDA issued a decision of Substantially Equivalent on November 29, 2016. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Quality Electrodynamics, LLC has at least 10 other 510(k) clearances on record.