DEN220066 is an FDA 510(k) submission for the BrainSee. This device is classified as a Prognostic Assessment Software Of Mild Cognitive Impairment (Class II - Special Controls, product code QWT).
Submitted by Darmiyan, Inc. (Berkeley, US). The FDA issued a Not Cleared (DENG) decision on January 11, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1454. 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..
| 510(k) Number | DEN220066 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 29, 2022 |
| Decision Date | January 11, 2024 |
| Days to Decision | 469 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | QWT - Prognostic Assessment Software Of Mild Cognitive Impairment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1454 |
| 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. |