Canvas Dx

Basic Information

• Brand Name: Canvas Dx
• Primary DI: 00860007260605
• Version / Model: 1.3.0
• Company Name: Cognoa, Inc.
• Labeler DUNS: 079400761
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-08
• Public Version: 3
• Public Version Date: 2022-05-16
• Public Version Status: Update
• Public Device Record Key: e0fd654c-79fe-40c8-b7ae-7e8fa99eb9b6

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QPF	Pediatric Autism Spectrum Disorder Diagnosis Aid	Neurology	882.1491	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65894	Neurodevelopmental disorder interpretive software	An interpretive, machine-learning-enabled software as a medical device (SaMD) application intended to be used to aid a healthcare professional in the diagnosis of a neurodevelopmental disorder (e.g., autism). It analyses patient demographics and questionnaire data from one or more sources (e.g., parent/caregiver, healthcare professionals) and provides an assessment. It is designed to be installed on an off-the-shelf device and intended primarily for use by a healthcare professional, however includes a parent/caregiver facing application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860007260605	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN200069	000