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..

1
Total
0
Cleared
469d
Avg days
2024
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

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

1 devices
1–1 of 1
Not Cleared Jan 11, 2024
BrainSee
DEN220066
Darmiyan, Inc.
Neurology · 469d

About Product Code QWT - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QWT since 2024, with 0 receiving FDA clearance (average review time: 469 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

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