FDA 510(k)

ds Head 32ch 3.0T

Номер K: K213351 · 2021-10-29

ЗаявительInvivo Corporation (Business Trade Name: Philips)

Дата решения2021-10-29

Код продуктаMOS

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

ds Head 32ch 3.0T 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 2021-10-29 under 510(k) number K213351. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the ds Head 32ch 3.0T?

ds Head 32ch 3.0T is a medical device that received FDA 510(k) clearance on 2021-10-29. The listed applicant is Invivo Corporation (Business Trade Name: Philips). The 510(k) number is K213351.

When did ds Head 32ch 3.0T receive FDA 510(k) clearance?

ds Head 32ch 3.0T received FDA 510(k) clearance on 2021-10-29, under 510(k) number K213351.

Who is the listed applicant for ds Head 32ch 3.0T?

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 Head 32ch 3.0T?

The FDA product code for ds Head 32ch 3.0T is MOS.

Другие записи, где Invivo Corporation (Business Trade Name: Philips) указан как заявитель

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

K232762dS Breast Coil 7ch 1.5T K2223258ch Запястье Кольцо 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

Связанные устройства (Код: 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 Грудной катушечный элементNeocoil, 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.

Официальный источник

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