Prognostic Assessment Software Of Mild Cognitive Impairment
QWT · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1454
Classification
FDA Product Code
QWT
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.1454
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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 Alzheimers 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.