QWT

Prognostic Assessment Software Of Mild Cognitive Impairment

Product code

QWT

Device name

Prognostic Assessment Software Of Mild Cognitive Impairment

Device class

Class 2

21 CFR

21 CFR 882.1454

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-01-11.