Neurology
encevis (2.1)
AIT Austrian Institute of Technology GmbH
FDA-cleared AI medical device
Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user
FDA Submission Metadata
- Submission number
- K240993
- Decision date
- September 2024
- FDA panel
- Neurology
- Product code
- OMB
- Clinical task (npj)
- detection/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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