Esaote, S.P.A. - FDA 510(k) Cleared Devices
Recent clearances: I-Genius (100019400), 6450 Ultrasound System (MyLabE80), S-scan Open (100001800)
68
Total
68
Cleared
0
Denied
FDA 510(k) Regulatory Record - Esaote, S.P.A. Radiology ✕
68 devices
Cleared
Jul 31, 2026
I-Genius (100019400)
Radiology
100d
Cleared
Apr 06, 2026
6450 Ultrasound System (MyLabE80)
Radiology
189d
Cleared
Mar 27, 2026
S-scan Open (100001800)
Radiology
21d
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
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