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).