QWT

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Prognostic Assessment Software Of Mild Cognitive Impairment

Device class

Class II (moderate risk)

Regulation

21 CFR 882.1454

Medical specialty

Neurology

FDA 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.

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