FDA 510(k)

HD 8Ch Wrist Array

N.º K: K252587 · 2026-04-14

Fecha de decisión2026-04-14

Código de productoMOS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

HD 8Ch Wrist Array is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen RF Tech Co., Ltd.. It received FDA 510(k) clearance on 2026-04-14 under 510(k) number K252587. 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 HD 8Ch Wrist Array?

HD 8Ch Wrist Array is a medical device that received FDA 510(k) clearance on 2026-04-14. The listed applicant is Shenzhen RF Tech Co., Ltd.. The 510(k) number is K252587.

When did HD 8Ch Wrist Array receive FDA 510(k) clearance?

HD 8Ch Wrist Array received FDA 510(k) clearance on 2026-04-14, under 510(k) number K252587.

Who is the listed applicant for HD 8Ch Wrist Array?

The FDA 510(k) record lists Shenzhen RF Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HD 8Ch Wrist Array?

The FDA product code for HD 8Ch Wrist Array is MOS.

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Otros registros que enlistan a Shenzhen RF Tech Co., Ltd. como solicitante

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 Only K252179GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only K2310851.5T HD T/R Knee Array (10-F34127)K2232031.5T 24E Posterior Array K2232258ch Bobina de Rodilla T/R K2232398ch Bobina de Muñeca

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Dispositivos relacionados (Código: MOS)

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, LLC 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.K252179GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive OnlyShenzhen RF Tech Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

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