# Prognostic Assessment Software Of Mild Cognitive Impairment
> **Product code: QWT** · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1454
## Classification
- **FDA Product Code:** QWT
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 882.1454
- **Review panel:** NE
- **Medical specialty:** Neurology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Prognostic assessment software of mild cognitive impairment. 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 too.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QWT)
---
*AI Analytics · CC0 1.0*