510(k) clearance
NEXT-Cue
- 510(k) number
- K261805
- Applicant
- Neuroxt, Inc.
- Decision date
- Oct 8, 2026
- Date received
- Jun 1, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QWT
- Device type
- Prognostic Assessment Software Of Mild Cognitive Impairment
- Device class
- Class II
- Regulation
- 21 CFR 882.1454
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Seoul, KR