4 devices · 4 companies · 2014 to 2019
BrainScope Company, Inc.: AI-enabled devices on FDA's list
4 devices from BrainScope Company, Inc., 2014 to 2019, from 4 companies across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 4 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| BrainScope TBIK190815 · 510(k) | Neurology | PIW | database entry | |
| Ahead 300K161068 · 510(k) | Neurology | PIW | database entry | |
| Brainscope Ahead 200K143643 · 510(k) | Neurology | PIW | database entry | |
| BrainScope Ahead 100DEN140025 · De Novo | Neurology | PIW | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.