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QuantX is a computer-aided diagnosis (CADx) software device used to assist radiologists in the assessment and characterization of breast abnormalities using MR image data. The software automatically registers images, and segments and analyzes user-selected regions of interest (ROI). QuantX extracts image data from the ROI to provide volumetric analysis and computer analytics based on morphological and enhancement characteristics. These imaging (or radiomic) features are then synthesized by an artificial intelligence algorithm into a single value, the QI score, which is analyzed relative to a database of reference abnormalities with known ground truth. QuantX is indicated for evaluation of patients presenting for high-risk screening, diagnostic imaging workup, or evaluation of extent of known disease. Extent of known disease refers to both the assessment of the boundary of a particular abnormality as well as the assessment of the total disease burden in a particular patient. In cases where multiple abnormalities are present, QuantX can be used to assess each abnormality independently. This device provides information that may be useful in the characterization of breast abnormalities during image interpretation. For the QI score and component radiomic features, the QuantX device provides comparative analysis to lesions with known outcomes using an image atlas and histogram display format. QuantX may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software also includes tools that allow users to measure and document images, and output in a structured report. Limitations: QuantX is not intended for primary interpretation of digital mammography images.

The device is a software-only post-processing system for patient breast images that includes analysis of MR images, and viewing ultrasound and mammographic images. MR images are acquired from a third-party acquisition device. The images can be loaded into the QuantX device manually or automatically if connected to a DICOMcompatible device. Users select and load the patient case to use the QuantX software tools in the examination of the images. Different types of MR sequences (T1, DCE, T2, DWI, etc.) can be viewed at the same time as mammography or ultrasound images from the same patient. QuantX includes image registration, and automated segmentation and analysis functions, based on a seed point indicated by the user. Users can select a ROI manually from the MR image, or use the automatic segmentation tool to obtain and accept a ROI. for input to the QuantX analytics. The QuantX analytics display the QI Most Enhancing Curve, the Average Enhancing Curve, and volume of the specified region. QuantX provides users the QI Score, based on the morphological and enhancement characteristics of the region of interest. The QuantX package provides comparative analysis for the QI score and its component element features to lesions with known ground truth (either biopsy- proven diagnosis or minimum one year follow-up negative scan for non-biopsied lesions) using an image atlas and histogram display format. A user experienced with the significance of such data will be able to view and interpret this additional information during the diagnosis of breast lesions. Users may select from a variety of information sources to make the diagnosis. The key features of the device are related categorization of lesions include the display of similar cases and the histogram of known lesions for various analytic features (included the Ql score). The QI Score is not a "probability of malignancy," but is intended for the organization of an online atlas (reference database) provided to the user as the Similar Case Database. The QI score is based on a machine learning algorithm, trained on a subset of features calculated on a segmented lesions.

QuantX is a quantitative image analysis software device used to assist radiologists in the assessment and characterization of breast abnormalities using MR image data. The software automatically registers images, and segments and analyzes user-selected regions of interest (ROI). QuantX extracts image data from the ROI to provide volumetric and surface area analysis. These imaging features are then displayed to the user in a dedicated analysis panel on the display monitor. When interpreted by a skilled physician, this device provides information that may be useful for screening and diagnosis. Patient management decisions should not be made based solely on the results of QuantX analysis. QuantX may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software also includes tools that allow users to measure and document images, and output in a structured report. Limitations: QuantX is not intended for primary interpretation of digital mammography images.

QuantX is a software program that analyzes patient breast images, and is designed to aid radiologists in the characterization of lesions. After MR images are acquired from a third-party acquisition device, they can be loaded into the QuantX database manually, or automatically if connected to a DICOM-compatible device. Users then select and load the patient case to use the QuantX software tools in the examination of the images. Different types of MR sequences (T1, DCE, T2, DWI, etc.) can be viewed at the same time as mammography or ultrasound images from the same patient. A variety of viewing tools are available to users. The MR images can be examined under different image planes (axial, sagittal, and coronal) as well as different image time points and slices. Users can use keyboard shortcuts or a scrolling mechanism to navigate through MR image slices. Colored axes serve as slice location markers for ease of pinpointing regions of interest (ROI). Images can be panned, changed in contrast, zoomed in or out. and measured. The Colormap feature visualizes contrast uptake (enhancement) studies, and a time intensity curve can be viewed for any location on the MR image. QuantX includes image registration, and automated segmentation and analysis functions, based on a seed point indicated by the user. Users can select a ROI manually from the MR image, or use the automatic segmentation tool to obtain and accept a ROI, for input to the QuantX analytics. The QuantX analytics display the QI Most Enhancing Curve, volume and surface area of the specified region. A user experienced with the significance of such data will be able to view and interpret this additional information during the diagnosis of breast lesions.