4 devices · 2 companies · 2024 to 2025
Eos Imaging: AI-enabled devices on FDA's list
4 devices from Eos Imaging, 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 (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 |
|---|---|---|---|---|
| AutoDensityK251078 · 510(k) | Radiology | QIH | database entry | |
| VEA AlignK251747 · 510(k) | Radiology | QIH | database entry | |
| VEA AlignK240582 · 510(k) | Radiology | QIH | database entry | |
| VEA AlignK231917 · 510(k) | Radiology | QIH | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.