MeVis AVM Contour is intended for use by qualified medical professionals working in the field of neurosurgery or radiotherapy planning to manually create target contours for regions of interest in the cranial region through semi-automatic registration of 2D digital subtraction angiography (DSA) images onto 3D computed tomography (CT) scans. The contours can be exported as DICOM RTStruct objects and are used in radiosurgery/-therapy treatment planning procedures to target specific brain regions. The created contours are intended for further review, editing and approval by radiosurgery/-therapy planning specialists in third-party radiosurgery/-therapy treatment planning systems (not part of this submission). The semi-automatic registration is restricted to/requires: • X-ray, 2D DSA and 3D CT images of the brain • X-ray images must be acquired in both frontal and sagittal direction Intended Patient Population MeVis AVM Contour is used for patients diagnosed with Arteriovenous Malformations (AVM) requiring stereotactic radiosurgery (SRS). These patients are adults, 18 years and older. Intended User Profile The intended users are qualified medical professionals, working in the field of neurosurgery or radiotherapy planning (Neurosurgeons and Radiation Oncologists).
A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).
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