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Prognostic Assessment Software Of Mild Cognitive Impairment

Page Type
Product Code
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.
Physical State
Software for analyzing multiple clinical inputs including, but not limited to, medical images, patient demographic information, and clinical test scores. The device may include software for pre-processing and reviewing the algorithmic inputs.
Technical Method
Software analyzes patient-specific clinical and imaging data to aid in prognosis of patients with mild cognitive impairment. May use algorithmic approaches to produce an output indicative of a patient’s likelihood for progression to more severe cognitive impairment, or will develop dementia, such as Alzheimer’s disease dementia.
Target Area
N/A
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1454
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QWT is linked to regulation 21CFR882.1454, which does not seem to exist yet. It may be pending at the moment.

Prognostic Assessment Software Of Mild Cognitive Impairment

Page Type
Product Code
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.
Physical State
Software for analyzing multiple clinical inputs including, but not limited to, medical images, patient demographic information, and clinical test scores. The device may include software for pre-processing and reviewing the algorithmic inputs.
Technical Method
Software analyzes patient-specific clinical and imaging data to aid in prognosis of patients with mild cognitive impairment. May use algorithmic approaches to produce an output indicative of a patient’s likelihood for progression to more severe cognitive impairment, or will develop dementia, such as Alzheimer’s disease dementia.
Target Area
N/A
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1454
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QWT is linked to regulation 21CFR882.1454, which does not seem to exist yet. It may be pending at the moment.