OsiriX is a DICOM image viewer for macOS that displays medical images and connects to any PACS, the picture archiving systems used by hospitals and imaging centres. It is offered as a free demo, OsiriX Lite, and as the commercial OsiriX MD, which the vendor states is cleared by the US FDA as a Class II medical device and complies with European Directive 93/42/EEC. The software runs on Intel and Apple Silicon Macs and is installed as an application on the user's own computer.
Pixmeo SARL, the company that develops and sells OsiriX, is a Swiss company based in the Geneva area. The product is a commercial licence, not open source, so customers cannot inspect or modify the code. Because the application runs on local hardware, the sovereignty question centres on the licence, the maintenance relationship and the device certification rather than on where patient images are stored. European hospitals that use it should check that their data flows, including connections to external PACS or cloud archives, meet their requirements.