Medical Device Manufacturer · IT , Genoa

Esaote, S.P.A. - FDA 510(k) Cleared Devices

67 submissions · 67 cleared · Since 2003

Total

Cleared

Denied

Esaote, S.P.A., is a medical diagnostic imaging company based in Genoa, Italy. The company specializes in ultrasound, MRI, and healthcare IT solutions for clinical settings.

Esaote has received 67 FDA 510(k) clearances from 67 total submissions since 2003. The company's regulatory portfolio is dominated by Radiology devices, representing 100% of its FDA submissions. Recent cleared devices include the MyLab ultrasound systems and Magnifico Open imaging platforms. The company remains actively engaged in FDA regulatory submissions, with the latest clearance in 2026.

Esaote's product portfolio centers on advanced ultrasound systems across multiple clinical specialties. The MyLab platform family serves radiology, cardiology, orthopedics, and women's health applications. The company also offers MRI systems and integrated healthcare IT connectivity solutions for diagnostic imaging workflows.

Explore the complete list of device names, product codes, and clearance dates in the database to review Esaote's full regulatory history.

510(k) submissions have been managed by Esaote, S.p.A. as regulatory consultant.

FDA 510(k) Regulatory Record - Esaote, S.P.A.

67 devices

1-12 of 67