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