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Esaote, S.p.A. FDA Approvals
0 new drug approvals and 11 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| I-Genius (100019400)510(k)Jul 31, 2026Radiology |
| 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)510(k)Apr 6, 2026Radiology |
| S-scan Open (100001800)510(k)Mar 27, 2026Radiology |
| Magnifico Open (100009900)510(k)Mar 5, 2026Radiology |
| 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)510(k)Nov 25, 2025Radiology |
| 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)510(k)Jun 18, 2025Radiology |
| 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)510(k)May 16, 2025Radiology |
| Magnifico Open (100009900); Magnifico MSK ( 100009910)510(k)Jun 26, 2024Radiology |
| 6440 MyLabX90510(k)Nov 29, 2023Radiology |
| Magnifico Open, Magnifico MSK510(k)Feb 4, 2022Radiology |
| 6430 MyLabX75, 6430 MyLab XPro75510(k)Sep 16, 2021Radiology |