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8 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Quantib BV
Authorized purpose: Brain WMH automatically labels, visualizes, and volumetrically quantifies white-matter hyperintensities from T2w FLAIR brain MR and returns segmentations, overlays, and measurements as complementary information for trained professionals and quantitative reporting in the labeled population.
Quantib BV
Authorized purpose: Support trained medical professionals in processing, visualizing, editing, and interpreting prostate MR studies, including structured PI-RADS scoring; diagnosis must not be made solely from the software analysis.
Quantib BV
Authorized purpose: Quantib Prostate versions 1.0 and 2.0 provide processing, visualization, editing, registration, mathematical or statistical analysis, semi-automatic segmentation, volume computation, and PI-RADS workflow support for prostate MRI. The software provides information that may assist trained medical professionals in interpreting prostate MR studies, and diagnosis must not be made solely from its analysis.
Quantib BV
Authorized purpose: Quantib Prostate is image post-processing software for processing, visualizing, and editing prostate MRI images. It supports registered multiparametric-MRI viewing, optional combined-image visualization, semi-automatic anatomical segmentation, volume computation, manual editing, and a structured PI-RADS workflow to assist trained medical professionals interpreting prostate MR studies; diagnosis should not be made solely from its analysis.
Quantib BV
Authorized purpose: Quantib ND is software for the labeled brain MRI image-analysis workflow, providing release-specific visualization, measurements, or decision-support outputs for professional review.
Quantib BV
Authorized purpose: Automatic brain-structure labeling, visualization, volumetric quantification, and WMH-candidate assessment as complementary information for trained professionals evaluating MR brain images and preparing quantitative reports.
Quantib BV
Authorized purpose: Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images; visualizes and quantifies WMH candidates and provides complementary information for trained medical professionals evaluating MR brain images and preparing quantitative reports.
QUANTIB BV
Authorized purpose: Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images; visualizes and quantifies WMH candidates and provides complementary information for trained medical professionals evaluating MR brain images and preparing quantitative reports.