Intended Use

Image processing software to perform viewing, processing and analysis of medical MRI and CT images, including semi-automatic labeling, visualization, and volumetric quantification of brain glioma (WHO Grade II-IV) for decision support by trained professionals.

Technology

Software-only device running on standard computers or virtual platforms, processing DICOM images from MRI and CT. Includes modules for capillary function (perfusion and diffusion analysis in MRI) and oncology virtual expert for delineating and quantifying brain glioma lesions with volumetric measures and comparison between longitudinal studies.

Performance

Validated with 425 MRI studies over 100 patients comparing semi-automatic segmentations against expert manual segmentations, showing equivalent performance to predicate device with strong Dice similarity coefficients (e.g., 0.706 and 0.822) for tumor region delineation and volume measurements, across various MRI scanner manufacturers and field strengths.

Predicate Devices

No predicate devices specified

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