510(k) K243558
K243558 is an FDA 510(k) premarket notification submitted by Cognoa, Inc. for the device "Canvas Dx". The FDA issued a decision of Substantially Equivalent on Apr 11, 2025. The device falls under product code QPF (Pediatric Autism Spectrum Disorder Diagnosis Aid), a Class II device regulated under 21 CFR 882.1491. Cognoa, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 11, 2025
- Date Received
- Nov 18, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pediatric Autism Spectrum Disorder Diagnosis Aid
- Device Class
- Class II
- Regulation Number
- 882.1491
- Review Panel
- NE
- Submission Type
A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients.