Neurology
autoSCORE (V 2.0.0)
Holberg EEG AS
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
- K243743
- Decision date
- April 2025
- FDA panel
- Neurology
- Product code
- OMB
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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