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Informational only. Not affiliated with any government agency. Verify details at the official source.

Devices

Esaote, S.p.A.

3 AI-enabled device listings under this company name on the FDA list. The name is copied as published. It is not a review of the company.

DateSubmissionDevicePanelCode
April 6, 2026K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)RadiologyIYN
March 27, 2026K260746S-scan Open (100001800)RadiologyLNH
March 5, 2026K251901Magnifico Open (100009900)RadiologyLNH