Device Dossier

Radiology DICOM image processing application software

Device Dossier for Radiology DICOM image processing application software (Radiology DICOM image processing application software, Class IIa, sponsor…

Intended purpose

to process DICOM image of brain medical resonance images. It performs segmentation and volumetric quantification of brain regions and white matter hyperintensities and generates a structured report for auxiliary diagnosis. It does not provide a medical diagnosis.

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