7 devices · 3 companies · 2023 to 2026
Esaote, S.p.A.: AI-enabled devices on FDA's list
7 devices from Esaote, S.p.A., 2023 to 2026, from 3 companies across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (7 of 7 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Esaote, S.p.A.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| 6450 Ultrasound SystemK253288 · 510(k) | Radiology | IYN | database entry | |
| S-scan OpenK260746 · 510(k) | Radiology | LNH | database entry | |
| Magnifico OpenK251901 · 510(k) | Radiology | LNH | database entry | |
| 7600 Ultrasound SystemK253310 · 510(k) | Radiology | IYN | database entry | |
| 6600 Ultrasound SystemK243253 · 510(k) | Radiology | IYN | database entry | |
| 6450 Ultrasound SystemK241671 · 510(k) | Radiology | IYN | database entry | |
| 6440 MyLabX90K230179 · 510(k) | Radiology | IYN | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.