FDA 510(k)

dS Breast Coil 7ch 1.5T

N.º K: K232762 · 2023-10-03

SolicitanteInvivo Corporation (Business Trade Name: Philips)

Fecha de decisión2023-10-03

Código de productoMOS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

dS Breast Coil 7ch 1.5T is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation (Business Trade Name: Philips). It received FDA 510(k) clearance on 2023-10-03 under 510(k) number K232762. 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 Breast Coil 7ch 1.5T?

dS Breast Coil 7ch 1.5T is a medical device that received FDA 510(k) clearance on 2023-10-03. The listed applicant is Invivo Corporation (Business Trade Name: Philips). The 510(k) number is K232762.

When did dS Breast Coil 7ch 1.5T receive FDA 510(k) clearance?

dS Breast Coil 7ch 1.5T received FDA 510(k) clearance on 2023-10-03, under 510(k) number K232762.

Who is the listed applicant for dS Breast Coil 7ch 1.5T?

The FDA 510(k) record lists Invivo Corporation (Business Trade Name: Philips) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for dS Breast Coil 7ch 1.5T?

The FDA product code for dS Breast Coil 7ch 1.5T is MOS.

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Otros registros que enlistan a Invivo Corporation (Business Trade Name: Philips) como solicitante

K2223258ch Bobina de Muñeca K2222571.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil K213735dS Sentinelle Breast 16ch 1.5T Coil K213727dS Sentinelle Breast 16ch 3.0T Coil K213351ds Head 32ch 3.0T

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 K252587HD 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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