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QWTClass II

Prognostic Assessment Software Of Mild Cognitive Impairment

21 CFR 882.1454 / Neurology
FDA source (opens on fda.gov)

QWT is the FDA product code for Prognostic Assessment Software Of Mild Cognitive Impairment, a class II device type, regulated under 21 CFR 882.1454. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QWT
Device name
Prognostic Assessment Software Of Mild Cognitive Impairment
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.
Regulation
21 CFR 882.1454
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QWT

By decision year
1 clearance under product code QWT with a decision year between 2024 and 2024, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QWT by decision year
YearClearances
20241

Applicants with the most clearances

Product code QWT
Applicants holding the most 510(k) clearances under product code QWT
ApplicantClearances
Darmiyan, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code