Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1454](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1454) → QWT — Prognostic Assessment Software Of Mild Cognitive Impairment

# QWT · Prognostic Assessment Software Of Mild Cognitive Impairment

_Neurology · 21 CFR 882.1454 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/QWT

## Overview

- **Product Code:** QWT
- **Device Name:** Prognostic Assessment Software Of Mild Cognitive Impairment
- **Regulation:** [21 CFR 882.1454](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1454)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)

## 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.

## Classification Rationale

Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks when considering the listed special controls and general controls.

## 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:

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN220066](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/QWT/DEN220066.md) | BrainSee | Darmiyan, Inc. | Jan 11, 2024 | DENG |

## Top Applicants

- Darmiyan, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/QWT](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/QWT)

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