QWT — Prognostic Assessment Software Of Mild Cognitive Impairment Class II

FDA Device Classification

Classification Details

Product Code
QWT
Device Class
Class II
Regulation Number
882.1454
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN220066darmiyanBrainSeeJanuary 11, 2024