K243558
- 510(k) number
- K243558
- Device name
- Canvas Dx
- Applicant
- Cognoa, Inc. CA · US
- Product code
- QPF — Pediatric Autism Spectrum Disorder Diagnosis Aid
- Decision date
- 2025-04-11
- Date received
- 2024-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243558.pdf
Official FDA record: K243558
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.