Using the System
Intended Use/Indications for Use
Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data.
The application can be used in clinical workflows that benefit from the co-registration of vascular image data as a planning or preplanning step for the treatment of cerebrovascular malformations.
Intended Patient Population
There are no demographic, regional or cultural limitations for patients. It is up to the user to decide if the system shall be used to assist a certain procedure.
Intended User Profile
The application is intended to be used by medical professionals and their assistants working in the field of neurosurgery, neuroradiology or radiotherapy planning.
Intended Use Environment
The system shall be used in a hospital office environment or rooms appropriate for surgical interventions.
The system can be installed on a standard Windows computer with the defined minimum requirements.
A more specific intended use environment (e.g., a specific planning station or navigation platform), may be present when the device is used in combination with other devices. The intended use environment is then stated in the technical file of the corresponding system.