TxRx Knee 15 Flare MR Coil 3.0T
K-Number: K163066 · 2016-11-29
ApplicantQuality Electrodynamics, LLC
Decision Date2016-11-29
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
TxRx Knee 15 Flare MR Coil 3.0T is a medical device manufactured by Quality Electrodynamics, LLC. It received FDA 510(k) clearance on 2016-11-29 under approval number K163066. 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 TxRx Knee 15 Flare MR Coil 3.0T?
TxRx Knee 15 Flare MR Coil 3.0T is a medical device that received FDA 510(k) clearance on 2016-11-29. It is manufactured by Quality Electrodynamics, LLC. The 510(k) number is K163066.
When was TxRx Knee 15 Flare MR Coil 3.0T approved by the FDA?
TxRx Knee 15 Flare MR Coil 3.0T received FDA 510(k) clearance on 2016-11-29, under approval number K163066.
What company makes TxRx Knee 15 Flare MR Coil 3.0T?
TxRx Knee 15 Flare MR Coil 3.0T is manufactured by Quality Electrodynamics, LLC.
What is the FDA product code for TxRx Knee 15 Flare MR Coil 3.0T?
The FDA product code for TxRx Knee 15 Flare MR Coil 3.0T is MOS.
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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.