FDA 510(k)

TxRx Knee 15 Flare MR Coil 3.0T

N.º K: K163066 · 2016-11-29

Fecha de decisión2016-11-29

Código de productoMOS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

TxRx Knee 15 Flare MR Coil 3.0T is the device name listed in this FDA 510(k) record. The listed applicant is Quality Electrodynamics, LLC. It received FDA 510(k) clearance on 2016-11-29 under 510(k) number K163066. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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. The listed applicant is Quality Electrodynamics, LLC. The 510(k) number is K163066.

When did TxRx Knee 15 Flare MR Coil 3.0T receive FDA 510(k) clearance?

TxRx Knee 15 Flare MR Coil 3.0T received FDA 510(k) clearance on 2016-11-29, under 510(k) number K163066.

Who is the listed applicant for TxRx Knee 15 Flare MR Coil 3.0T?

The FDA 510(k) record lists Quality Electrodynamics, LLC as the applicant. This does not by itself establish the device manufacturer.

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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Otros registros que enlistan a Quality Electrodynamics, LLC como solicitante

K242006SureWave Elastography (Q7000225)K223429Contour Knee K200477Flex Body Speeder K193140Flex Body SPEEDER K183111Contour 24 K181697Flex SPEEDER de Pie/Ánkle 16ch

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Fuente oficial

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