OsiriX, being a free open-source software (FOSS), is not certified as a commercial medical device for primary diagnostic imaging. Hence, OsiriX is not FDA/CE-1 certified. In some countries (for example, USA and Europe), you can only use OsiriX as a reviewing, research or teaching software, not for primary diagnostic, used in clinical worklfow and/or for patient care.
For these reasons, several commercial versions of OsiriX exist. They are certified as medical devices for primary diagnostic imaging.
The OsiriX Team (Pixmeo SARL) distributes a certified version for primary diagnostic imaging: OsiriX MD.