FDA 510(k)

Cognitive Function Neuroimaging (cfNI) Software (1.0.0)

Número K: K253015 · 2026-06-12

Data da decisão2026-06-12

Código do produtoOLU

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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