Canvas Dx

GUDID 00860007260605

Canvas Dx is a prescription diagnostic aid to healthcare professionals (HCP) considering the diagnosis of Autism Spectrum Disorder (ASD) in patients 18 months through 72 months of age at risk for developmental delay. The patient’s caregiver uses a smartphone application (“App”) to fill out a caregiver questionnaire and to make video recordings of behavior at home, and then the physician fills out a medical questionnaire online. The results are made available to the physician.

Cognoa, Inc.

Neurodevelopmental disorder interpretive software

• Primary Device ID: 00860007260605
• NIH Device Record Key: e0fd654c-79fe-40c8-b7ae-7e8fa99eb9b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Canvas Dx
• Version Model Number: 1.1.0
• Company DUNS: 079400761
• Company Name: Cognoa, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com
• Phone: 1-866-426-4662
• Email: support@cognoa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007260605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200069

FDA Product Code

• QPF: Pediatric Autism Spectrum Disorder Diagnosis Aid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-16
• Device Publish Date: 2021-12-08