Esaote, S.p.A.
FDA 510(k) & PMA Approved Devices — 24 products
Total Devices24
Categories2
Latest Approval2026-04-06
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | IYN | 2026-04-06 | View |
| 510(k) | K260746 | S-scan Open (100001800) | LNH | 2026-03-27 | View |
| 510(k) | K251901 | Magnifico Open (100009900) | LNH | 2026-03-05 | View |
| 510(k) | K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | IYN | 2025-11-25 | View |
| 510(k) | K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) | IYN | 2025-06-18 | View |
| 510(k) | K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | IYN | 2025-05-16 | View |
| 510(k) | K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910) | LNH | 2024-06-26 | View |
| 510(k) | K230179 | 6440 MyLabX90 | IYN | 2023-11-29 | View |
| 510(k) | K212419 | Magnifico Open, Magnifico MSK | LNH | 2022-02-04 | View |
| 510(k) | K212021 | 6430 MyLabX75, 6430 MyLab XPro75 | IYN | 2021-09-16 | View |
| 510(k) | K192157 | 6450 Ultrasound system | IYN | 2019-11-22 | View |
| 510(k) | K191072 | 7410 Ultrasound System (MyLabSigma) | IYN | 2019-06-10 | View |
| 510(k) | K190989 | 6400 Ultrasound System (MyLabX6, MyLabX7) | IYN | 2019-05-10 | View |
| 510(k) | K183685 | O-Scan | LNH | 2019-01-22 | View |
| 510(k) | K183191 | 6420 Ultrasound System | IYN | 2018-12-04 | View |
| 510(k) | K180592 | G-scan Brio | LNH | 2018-03-30 | View |
| 510(k) | K173291 | 6440 Ultrasound System | IYN | 2018-01-12 | View |
| 510(k) | K163082 | 6200 Ultrasound System and 6250 Ultrasound System | IYN | 2017-03-16 | View |
| 510(k) | K161973 | G-scan Brio, S-scan | LNH | 2016-10-25 | View |
| 510(k) | K162290 | MyLabSix CrystaLine | IYN | 2016-10-14 | View |
| 510(k) | K161359 | 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System | IYN | 2016-07-19 | View |
| 510(k) | K161238 | S-scan | LNH | 2016-07-08 | View |
| 510(k) | K153277 | 6200 Ultrasound System and 6250 Ultrasound System | IYN | 2016-05-04 | View |
| 510(k) | K153039 | MRI Dynamic Analysis Plus | LNH | 2016-01-08 | View |
No matching devices.