Definitions

• CustusX function: CustusX provides guidance during a clinical procedure by enabling navigation in images. Patient information is assembled, processed and presented in a way useful to the operator. New information can also be created based on existing data. CustusX is a research platform and is not approved for clinical use.
• Standard procedure: A fully approved method for performing the clinical procedure, using existing state-of-the-art practice and CE-approved equipment. The procedure can use an approved navigation system or be designed in such a way that navigation is not necessary.

Requirements for using CustusX in a standard procedure

• CustusX shall be used only as support. The application shall never be used as the only source of guidance. Standard procedure shall always be used for obtaining information and making decisions, with CustusX providing additional information only. Is must be possible to complete the procedure without CustusX. Whenever additional information is retrieved from CustusX, the information shall be verified by comparing with the standard procedure.
• CustusX shall only contains anonymized patient data. All patient data is anonymized prior to or during import to CustusX.
• CustusX shall only by used as a part of a clinical study. The use of CustusX is then covered by the regulations for clinical studies, i.e ISO 14155.

CustusX shall not be used with patients under other conditions.