QWT — Prognostic Assessment Software Of Mild Cognitive Impairment Class II
FDA product code QWT covers "Prognostic Assessment Software Of Mild Cognitive Impairment", a Class II medical device regulated under 21 CFR 882.1454. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QWT
- Device Class
- Class II
- Regulation Number
- 882.1454
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220066 | darmiyan | BrainSee | January 11, 2024 |