Esaote, S.P.A. - FDA 510(k) Cleared Devices
65
Total
65
Cleared
0
Denied
Esaote, S.P.A. has 65 FDA 510(k) cleared radiology devices. Based in Genoa, IT.
Latest FDA clearance: Mar 2026. Active since 2003.
Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Esaote, S.P.A.
65 devices
Cleared
Mar 05, 2026
Magnifico Open (100009900)
Radiology
258d
Cleared
Nov 25, 2025
7600 Ultrasound System (MyLabC25)
Radiology
57d
Cleared
Jun 18, 2025
6600 Ultrasound System (MyLabA50)
Radiology
246d
Cleared
May 16, 2025
6450 Ultrasound System (MyLabE80)
Radiology
339d
Cleared
Jun 26, 2024
Magnifico Open (100009900)
Radiology
63d
Cleared
Nov 29, 2023
6440 MyLabX90
Radiology
310d
Cleared
Feb 04, 2022
Magnifico Open, Magnifico MSK
Radiology
184d
Cleared
Sep 16, 2021
6430 MyLabX75, 6430 MyLab XPro75
Radiology
80d
Cleared
Nov 22, 2019
6450 Ultrasound system
Radiology
105d
Cleared
Jun 10, 2019
7410 Ultrasound System (MyLabSigma)
Radiology
49d
Cleared
May 10, 2019
6400 Ultrasound System (MyLabX6, MyLabX7)
Radiology
25d
Cleared
Jan 22, 2019
O-Scan
Radiology
25d
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