3 devices · 1 company · 2025 to 2026
AZmed: AI-enabled devices on FDA's list
3 devices from AZmed, 2025 to 2026, from 1 company across 3 product codes. 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.
Product codes from AZmed
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| RayvolveK260378 · 510(k) | Radiology | QBS | database entry | |
| Rayvolve LNK243831 · 510(k) | Radiology | MYN | database entry | |
| Rayvolve PTX-PEK243808 · 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.