Neurology
Cognoa ASD Diagnosis Aid
Cognoa, Inc.
FDA
FDA-cleared AI medical device
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.
FDA Submission Metadata
- Submission number
- DEN200069
- Decision date
- June 2021
- FDA panel
- Neurology
- Product code
- QPF
- Clinical task (npj)
- diagnosis
- Data modality (npj)
- Images
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
Regulatory Approvals
FDA
US FDA De Novo
DEN200069
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