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FDA 510(k)

dS Small Extremity 16CH 1.5T Coil

N.º K: K162863 · 2016-11-07

SolicitanteInvivo Therapeutics Corporation
Fecha de decisión2016-11-07
Código de productoMOS
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

dS Small Extremity 16CH 1.5T Coil is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Therapeutics Corporation. It received FDA 510(k) clearance on 2016-11-07 under 510(k) number K162863. 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 dS Small Extremity 16CH 1.5T Coil?

dS Small Extremity 16CH 1.5T Coil is a medical device that received FDA 510(k) clearance on 2016-11-07. The listed applicant is Invivo Therapeutics Corporation. The 510(k) number is K162863.

When did dS Small Extremity 16CH 1.5T Coil receive FDA 510(k) clearance?

dS Small Extremity 16CH 1.5T Coil received FDA 510(k) clearance on 2016-11-07, under 510(k) number K162863.

Who is the listed applicant for dS Small Extremity 16CH 1.5T Coil?

The FDA 510(k) record lists Invivo Therapeutics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for dS Small Extremity 16CH 1.5T Coil?

The FDA product code for dS Small Extremity 16CH 1.5T Coil is MOS.

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Dispositivos relacionados (Código: MOS)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Bobina de MamaNeocoil, LLCK252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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