Redirecting to Store...
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.
- OsiriX MD is certified for medical imaging in Brazil (ANVISA).