3 devices · 2 companies · 2024 to 2025
Augmedics, Ltd.: AI-enabled devices on FDA's list
3 devices from Augmedics, Ltd., 2024 to 2025, from 2 companies across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 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 |
|---|---|---|---|---|
| xvision Spine systemK251639 · 510(k) | Neurology | SBF | database entry | |
| xvision Spine systemK250255 · 510(k) | Neurology | SBF | database entry | |
| xvision Spine SystemK241481 · 510(k) | Neurology | SBF | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.