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