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FDA 510(k)

3T 32 Canal Coils para la Cabeza

N.º K: K182737 · 2019-04-12

SolicitanteNova Medical, Inc.
Fecha de decisión2019-04-12
Código de productoMOS
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

3T 32 Channel Head Coil is the device name listed in this FDA 510(k) record. The listed applicant is Nova Medical, Inc.. It received FDA 510(k) clearance on 2019-04-12 under 510(k) number K182737. 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 3T 32 Channel Head Coil?

3T 32 Channel Head Coil is a medical device that received FDA 510(k) clearance on 2019-04-12. The listed applicant is Nova Medical, Inc.. The 510(k) number is K182737.

When did 3T 32 Channel Head Coil receive FDA 510(k) clearance?

3T 32 Channel Head Coil received FDA 510(k) clearance on 2019-04-12, under 510(k) number K182737.

Who is the listed applicant for 3T 32 Channel Head Coil?

The FDA 510(k) record lists Nova Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3T 32 Channel Head Coil?

The FDA product code for 3T 32 Channel Head 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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