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United States of America

OsiriX MD is cleared by the FDA, as a Class II Medical Device, for diagnostic imaging in medicine.

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European Union & Switzerland

OsiriX MD complies with European Directive 93/42/ EEC concerning medical devices (CE labeled). Under this directive, it is regarded as a Class IIa product.

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Japan

OsiriX MD complies with the "Act on Securing Quality, Effectiveness, and Safety of Pharmaceuticals and Medical Devices" (PMDA). OsiriX MD is regarded as a Class II medical device.

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Brazil

OsiriX MD is certified for medical imaging in Brazil (ANVISA).

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India

OsiriX MD is authorized for import and distribution in India by the Central Drugs Standard Control Organization (CDSCO).

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Certified Medical Device

FDA cleared: OsiriX MD is cleared by the FDA, as a Class II Medical Device, for diagnostic imaging in medicine.
CE labeled: OsiriX MD complies with European Directive 93/42/ EEC concerning medical devices (CE labeled). Under this directive, it is regarded as a Class IIa product.
ISO 13485: OsiriX MD is developed by Pixmeo following a Quality Management System fulfilling the requirements of the ISO 13485 standard.
Japan PMDA: OsiriX MD complies with the "Act on Securing Quality, Effectiveness, and Safety of Pharmaceuticals and Medical Devices" (PMDA). OsiriX MD is regarded as a Class II medical device.
ANVISA: OsiriX MD is certified for medical imaging in Brazil (ANVISA).
India CDSCO: OsiriX MD is authorized for import and distribution in India by the Central Drugs Standard Control Organization (CDSCO).