FDA 510(k)

dS Sentinelle Breast 16ch 3.0T Coil

Número K: K213727 · 2022-08-08

RequerenteInvivo Corporation (Business Trade Name: Philips)

Data da decisão2022-08-08

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

dS Sentinelle Breast 16ch 3.0T Coil 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 2022-08-08 under 510(k) number K213727. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the dS Sentinelle Breast 16ch 3.0T Coil?

dS Sentinelle Breast 16ch 3.0T Coil is a medical device that received FDA 510(k) clearance on 2022-08-08. The listed applicant is Invivo Corporation (Business Trade Name: Philips). The 510(k) number is K213727.

When did dS Sentinelle Breast 16ch 3.0T Coil receive FDA 510(k) clearance?

dS Sentinelle Breast 16ch 3.0T Coil received FDA 510(k) clearance on 2022-08-08, under 510(k) number K213727.

Who is the listed applicant for dS Sentinelle Breast 16ch 3.0T Coil?

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 Sentinelle Breast 16ch 3.0T Coil?

The FDA product code for dS Sentinelle Breast 16ch 3.0T Coil is MOS.

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Outros registros que listam Invivo Corporation (Business Trade Name: Philips) como candidato(a)

K232762dS Breast Coil 7ch 1.5T K2223258ch Fio de Pulso K2222571.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil K213735dS Sentinelle Breast 16ch 1.5T 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 PeitoNeocoil, 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.

Fonte oficial

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