Neurology
EyeBOX
Oculogica, Inc.
FDA-cleared AI medical device
A traumatic brain injury eye movement assessment aid is a prescription device that uses a patients tracked eye movements to provide an interpretation of the functional condition of the patients brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.
FDA Submission Metadata
- Submission number
- K201841
- Decision date
- September 2020
- FDA panel
- Neurology
- Product code
- QEA
- 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.
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