NEXT-Cue— 510(k) K261805

Name: FDA 510(k) clearance K261805
Creator: U.S. Food and Drug Administration
Published: 2026-10-08

Substantially Equivalent

Neuroxt, Inc.

FDA 510(k) clearance K261805 for NEXT-Cue, Substantially Equivalent on 2026-10-08. Applicant: Neuroxt, Inc.. Device class: 2.

Summary

NEXT-Cue from Neuroxt is filed under QWT, prognostic assessment software of mild cognitive impairment. The record doesn't describe its inputs or outputs beyond that product code.

Class II, 21 CFR 882.1454. The Neurology panel reviewed it as a Traditional 510(k).

Neuroxt filed from Seoul, South Korea. Review took 129 days (June 1 to October 8, 2026).

Clearance details

Applicant: Neuroxt, Inc.
Product code: Product code QWT
Device class: Class 2
Regulation: 21 CFR 882.1454
Advisory panel: Neurology
Date received: 2026-06-01
Decision date: 2026-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.