Product code QWT

Device name

Prognostic Assessment Software Of Mild Cognitive Impairment

Medical specialty

Neurology

Device class

2

Regulation number

882.1454

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset