FDA 510(k)

16ch T/R Knee Coil

K-Number: K162029 · 2016-10-18

Decision Date2016-10-18

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

16ch T/R Knee Coil is a medical device manufactured by Quality Electrodynamics, LLC. It received FDA 510(k) clearance on 2016-10-18 under approval number K162029. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 16ch T/R Knee Coil?

16ch T/R Knee Coil is a medical device that received FDA 510(k) clearance on 2016-10-18. It is manufactured by Quality Electrodynamics, LLC. The 510(k) number is K162029.

When was 16ch T/R Knee Coil approved by the FDA?

16ch T/R Knee Coil received FDA 510(k) clearance on 2016-10-18, under approval number K162029.

What company makes 16ch T/R Knee Coil?

16ch T/R Knee Coil is manufactured by Quality Electrodynamics, LLC.

What is the FDA product code for 16ch T/R Knee Coil?

The FDA product code for 16ch T/R Knee Coil is MOS.

Other Devices by Quality Electrodynamics, LLC

K16262316ch T/R Hand Wrist Coil K162966TxRx Knee 15 Flare MR Coil 1.5T K163066TxRx Knee 15 Flare MR Coil 3.0T K16119316ch Tx/Rx Knee SPEEDER K173446Contour 24 K1629468ch Knee-Foot SPEEDER

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Related Devices (Code: MOS)

K16262316ch T/R Hand Wrist CoilQuality Electrodynamics, LLC K162966TxRx Knee 15 Flare MR Coil 1.5TQuality Electrodynamics, LLC K163066TxRx Knee 15 Flare MR Coil 3.0TQuality Electrodynamics, LLC K162863dS Small Extremity 16CH 1.5T CoilInvivo Therapeutics Corporation K162079TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc. K162177dS FootAnkle I6CH 1.5T CoilInvivo Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.