BrainScope Ahead 100 is an AI-enabled medical device from BRAINSCOPE COMPANY, INC, listed by FDA (De Novo, DEN140025) with a decision date of 2014-11-17. Review panel: Neurology.
| FDA submission number | DEN140025 |
|---|---|
| Pathway | De Novo |
| Company | BRAINSCOPE COMPANY, INC |
| Review panel (specialty) | Neurology |
| FDA decision date | 2014-11-17 |
| Decision | Unknown |
| Product code | PIW |
| Classification | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid |
| Device class | 2 |
| Regulation number | 882.1450 |
| Review time (calendar days) | 89 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.