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FDA 510(k)

Cognitive Function Neuroimaging (cfNI) Software (1.0.0)

K-Number: K253015 · 2026-06-12

ApplicantVoxNeuro, Inc.
Decision Date2026-06-12
Product CodeOLU
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: OLU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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