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FDA

OsiriX MD is cleared by the FDA as a Class II Medical Device for diagnostic imaging in medicine. The 510(k) number is K101342.

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