QWT · Class II · 21 CFR 882.1454

FDA Product Code QWT: Prognostic Assessment Software Of Mild Cognitive Impairment

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.

Leading manufacturers include Darmiyan, Inc. and Neuroxt, Inc..

2
Total
1
Cleared
299d
Avg days
2024
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 129d recently vs 469d historically

FDA 510(k) Cleared Prognostic Assessment Software Of Mild Cognitive Impairment Devices (Product Code QWT)

2 devices
1–2 of 2
Cleared Oct 08, 2026
NEXT-Cue
K261805
Neuroxt, Inc.
Neurology · 129d
Not Cleared Jan 11, 2024
BrainSee
DEN220066
Darmiyan, Inc.
Neurology · 469d

About Product Code QWT - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QWT since 2024, with 1 receiving FDA clearance (average review time: 299 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - QWT Product Code

Recent submissions under QWT have taken an average of 129 days to reach a decision - down from 469 days historically, suggesting improved FDA processing for this classification.

QWT devices are reviewed by the Neurology panel. Browse all Neurology devices →