FDA 510(k)

Cognitive Function Neuroimaging (cfNI) Software (1.0.0)

Номер K: K253015 · 2026-06-12

Дата решения2026-06-12

Код продуктаOLU

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Cognitive Function Neuroimaging (cfNI) Software (1.0.0) is the device name listed in this FDA 510(k) record. The listed applicant is VoxNeuro, Inc.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K253015. The device is classified under product code OLU. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Cognitive Function Neuroimaging (cfNI) Software (1.0.0)?

Cognitive Function Neuroimaging (cfNI) Software (1.0.0) is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is VoxNeuro, Inc.. The 510(k) number is K253015.

When did Cognitive Function Neuroimaging (cfNI) Software (1.0.0) receive FDA 510(k) clearance?

Cognitive Function Neuroimaging (cfNI) Software (1.0.0) received FDA 510(k) clearance on 2026-06-12, under 510(k) number K253015.

Who is the listed applicant for Cognitive Function Neuroimaging (cfNI) Software (1.0.0)?

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

What is the FDA product code for Cognitive Function Neuroimaging (cfNI) Software (1.0.0)?

The FDA product code for Cognitive Function Neuroimaging (cfNI) Software (1.0.0) is OLU.

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: OLU)

K240420NeuroField Analysis SuiteNeurofield, Inc.K222838iSyncBrain©-CiMediSync, Inc.K212684BrainView QEEG SoftwareMedeia, Inc.K202588BNA PlatformElminda, Ltd.K191432cortiQ PROG.Tec Medical Engineering GmbH K171414qEEG-ProBrainmaster Technologies, Inc.

Официальный источник

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