Neurology
BrainScope TBI
BrainScope Company, Inc.
A prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient's brain in the setting of trauma. The Brain Injury Adjunctive Interpretive EEG Assessment Aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.
FDA Submission Metadata
- Submission number
- K190815
- Decision date
- September 2019
- FDA panel
- Neurology
- Product code
- PIW
- Clinical task (npj)
- diagnosis
- Data modality (npj)
- Signals
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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