Esaote
Privately held Italian manufacturer of ultrasound and dedicated MRI imaging systems.
Updated Jul 1, 2026
Headquartered in Italy
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Overview
About Esaote
Esaote manufactures ultrasound imaging systems and dedicated MRI systems used in orthopedics, radiology, and cardiology, and is a privately held manufacturer headquartered in Genoa, Italy.
Products
- Ultrasound imaging systems
- Dedicated MRI systems
Markets Served
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Related
Certifications
ISO 13485
The international quality management system standard specific to medical device manufacturers, referenced by most major regulators.
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CE Mark
The conformity mark required to sell medical devices in the EU/EEA, issued once a device meets EU MDR or IVDR requirements.
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FDA 510(k) / PMA
US market authorization for medical devices via the FDA's 510(k), De Novo, or PMA pathways.
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Related
Regulatory Pathways
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