FDA 510(k)

Philips CT Big Bore Sliding Gantry Configuration

Номер K: K181797 · 2018-08-03

ЗаявительPhillips Medical Systems (Cleveland), Inc.

Дата решения2018-08-03

Код продуктаJAK

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Philips CT Big Bore Sliding Gantry Configuration is the device name listed in this FDA 510(k) record. The listed applicant is Phillips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2018-08-03 under 510(k) number K181797. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Philips CT Big Bore Sliding Gantry Configuration?

Philips CT Big Bore Sliding Gantry Configuration is a medical device that received FDA 510(k) clearance on 2018-08-03. The listed applicant is Phillips Medical Systems (Cleveland), Inc.. The 510(k) number is K181797.

When did Philips CT Big Bore Sliding Gantry Configuration receive FDA 510(k) clearance?

Philips CT Big Bore Sliding Gantry Configuration received FDA 510(k) clearance on 2018-08-03, under 510(k) number K181797.

Who is the listed applicant for Philips CT Big Bore Sliding Gantry Configuration?

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

What is the FDA product code for Philips CT Big Bore Sliding Gantry Configuration?

The FDA product code for Philips CT Big Bore Sliding Gantry Configuration is JAK.

Связанные клинические исследования

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.

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Связанные устройства (Код: JAK)

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm Corporation K253836FCT iStream Phase 2Fujifilm Corporation K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company K253770CardIQ SuiteGE Medical Systems SCS K253560Enhanced Boundary for PCCTGe Medical Systems, LLC

Официальный источник

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