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Device prognostic assessment software of mild cognitive impairment
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.
Product CodeQWT
Regulation Number 882.1454
Device Class 2


Premarket Reviews
ManufacturerDecision
DARMIYAN, INC.
  GRANTED 1

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