← Product Code [QWT](/productcode/QWT) · K261805

# NEXT-Cue (K261805)

_Neuroxt, Inc. · QWT · Oct 8, 2026 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K261805

## Device Facts

- **Applicant:** Neuroxt, Inc.
- **Product Code:** [QWT](/productcode/QWT.md)
- **Decision Date:** Oct 8, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.1454
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

Prognostic assessment software of mild cognitive impairment is a prescription-only device that combines information from multiple clinical data sources to produce an output indicative of the likelihood that a patient diagnosed with mild cognitive impairment will progress to more severe forms of cognitive impairment, or will develop dementia, such as Alzheimer's disease dementia, within a specified period of time. This device is intended for adjunctive use and not intended as a stand-alone diagnostic or prognostic tool.

## Special Controls

In combination with the general controls of the FD&C Act, the prognostic assessment software of mild cognitive impairment is subject to the following special controls:

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**Source:** [https://fda.innolitics.com/device/K261805](https://fda.innolitics.com/device/K261805)

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