Neurology · 510(k) · 2025
Canvas Dx
Cognoa, Inc.. Cleared by FDA on 11 April 2025 under submission K243558, product code QPF (pediatric autism spectrum disorder diagnosis aid). What FDA's record says, in FDA's words.
Device record · K243558
- Device. Canvas DxDEVICE
- Company. Cognoa, Inc.COMPANY
- Decision. 11 April 2025, 510(k), substantially equivalent (traditional review); received 18 November 2024DECISION
- Panel. NeurologyPANEL
- Product code. QPF, Pediatric Autism Spectrum Disorder Diagnosis AidCODE
- Regulation. 21 CFR 882.1491, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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. The Cognoa ASD Diagnosis Aid 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. Data Collection A caregiver facing mobile application, which provides Device Input 1 (Caregiver Questionnaire) A caregiver facing mobile application, which provides Device Input 1 (Caregiver Questionnaire) C anvas Dx S UMMARY OF NON-CLINICAL TESTING Testing was performed in accordance with IEC 62304:2006 to demonstrate safety based on current industry standards. The results of these tests indicate that Canvas Dx is substantially equivalent to the
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QPF. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QPF, in Neurology, from Cognoa, Inc., or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.