Information system software, application program, patient record

Intended purpose

StrokeViewer is an image processing software application that analyzes CT scans and MR perfusion scans of the brain to indicate areas of the brain of suspected stroke patients to indicate areas of the brain with suspected anterior circulation large vessel occlusion (LVO) or hemorrhagic stroke. Additionally, StrokeViewer performs calculations to quantify collateral circulation, brain perfusion, hemorrhagic stroke volume, and ASPECTS. StrokeViewer provides this information to the user to include it as additional data for diagnosis of stroke in suspected stroke patients for the adult population, and to determine treatment. There is no change to the standard of care assessment of suspected stroke patients where the healthcare professional assesses the medical images. StrokeViewer only provides additional imaging data and numerical data that may be taken into consideration by a healthcare professional. StrokeViewer is not intended to be used as a standalone diagnostic tool, and StrokeViewer output should always be interpreted in the context of clinical information about the patient rather than in isolation. The StrokeViewer output is provided as a DICOM report/series.