Cleared Traditional

Canvas Dx

K243558 · Cognoa, Inc. · Neurology
Apr 2025
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K243558 is an FDA 510(k) clearance for the Canvas Dx, a Pediatric Autism Spectrum Disorder Diagnosis Aid (Class II — Special Controls, product code QPF), submitted by Cognoa, Inc. (Palo Alto, US). The FDA issued a Cleared decision on April 11, 2025, 144 days after receiving the submission on November 18, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1491.

Submission Details

510(k) Number K243558 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2024
Decision Date April 11, 2025
Days to Decision 144 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code QPF — Pediatric Autism Spectrum Disorder Diagnosis Aid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1491
Definition 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.