| Decision | Number | Device | Company | Panel |
|---|---|---|---|---|
| 2026-04-06 | K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.p.A. | Radiology |
| 2026-03-27 | K260746 | S-scan Open (100001800) | Esaote, S.p.A. | Radiology |
| 2026-03-05 | K251901 | Magnifico Open (100009900) | Esaote, S.p.A. | Radiology |
| 2025-11-25 | K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | Esaote, S.P.A. | Radiology |
| 2025-06-18 | K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) | Esaote S.p.A. | Radiology |
| 2025-05-16 | K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote S.p.A. | Radiology |
| 2023-11-29 | K230179 | 6440 MyLabX90 | Esaote S.p.A. | Radiology |