9 devices · 2 companies · 2021 to 2026
DeepHealth, Inc.: AI-enabled devices on FDA's list
9 devices from DeepHealth, Inc., 2021 to 2026, from 2 companies across 3 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (8 of 9 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from DeepHealth, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Saige-DxK253825 · 510(k) | Radiology | QDQ | database entry | |
| BACK254131 · 510(k) | Radiology | QIH | database entry | |
| Saige-DxK251873 · 510(k) | Radiology | QDQ | database entry | |
| Saige-DensityK243705 · 510(k) | Radiology | QIH | database entry | |
| Saige-DxK243688 · 510(k) | Radiology | QDQ | database entry | |
| Saige-DxK241747 · 510(k) | Radiology | QDQ | database entry | |
| Saige-DensityK222275 · 510(k) | Radiology | QIH | database entry | |
| Saige-DxK220105 · 510(k) | Radiology | QDQ | database entry | |
| Saige-QK203517 · 510(k) | Radiology | QFM | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.