510(k) DEN220066
DEN220066 is an FDA 510(k) premarket notification submitted by Darmiyan, Inc. for the device "BrainSee". The FDA issued a decision of De Novo Granted on January 11, 2024. The device falls under product code QWT (Prognostic Assessment Software Of Mild Cognitive Impairment), a Class II device regulated under 21 CFR 882.1454.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- January 11, 2024
- Date Received
- September 29, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prognostic Assessment Software Of Mild Cognitive Impairment
- Device Class
- Class II
- Regulation Number
- 882.1454
- Review Panel
- NE
- Submission Type
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.