FDA 510(k)

Aquilion ONE самоходная платформа для сканирования IVR-CT, CGBA-034A

Номер K: K182223 · 2018-09-14

Дата решения2018-09-14

Код продуктаJAK

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A is the device name listed in this FDA 510(k) record. The listed applicant is Canon Medical Systems, USA. It received FDA 510(k) clearance on 2018-09-14 under 510(k) number K182223. 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 Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A?

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A is a medical device that received FDA 510(k) clearance on 2018-09-14. The listed applicant is Canon Medical Systems, USA. The 510(k) number is K182223.

When did Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A receive FDA 510(k) clearance?

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A received FDA 510(k) clearance on 2018-09-14, under 510(k) number K182223.

Who is the listed applicant for Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A?

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

What is the FDA product code for Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A?

The FDA product code for Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A 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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