# K243558: Canvas Dx

- Pathway: 510(k) (Traditional)
- Applicant: Cognoa, Inc.
- Decided: Apr 11, 2025 after 144 days
- Product code: QPF (Pediatric Autism Spectrum Disorder Diagnosis Aid)
- Device class: 2
- Regulation: 21 CFR 882.1491
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN200069 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200069: Cognoa ASD Diagnosis Aid, Cognoa, Inc. (2021) Summary page 6.

## Indications for use
Canvas Dx is intended for use by healthcare providers as an aid in the diagnosis of Autism Spectrum Disorder (ASD) for patients ages 18 months through 72 months who are at risk for developmental delay based on concerns of a parent, caregiver, or healthcare provider. The device is not intended for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process.

Source page: https://510kreport.com/device/K243558
Methodology: https://510kreport.com/methodology