MR DWI/FLAIR Measurement V1.0 is an image processing application indicated for use in the analysis of: (1) MR Diffusion-weighted imaging (DWI) (2) MR FLAIR images. The device is intended to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians in the imaging assessment workflow: • computation of the map relative to the water diffusion, i.e., ADC map; • extraction and communication of metrics derived from the above map, i.e., hypointense area on ADC, and FLAIR series as well as ratios with contralateral information on FLAIR images. The results of MR DWI/FLAIR Measurement V1.0 are intended to be used in conjunction with other patient information and, based on professional judgment, to assist the clinician in the medical imaging assessment. Trained professionals are responsible for viewing the full set of native images per the standard of care. MR DWI/FLAIR Measurement V1.0 can be integrated and deployed through technical platforms.
A software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.
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