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510(k) Data Aggregation

    K Number
    K170195
    Device Name
    QuantX
    Manufacturer
    Quantitative Insights, Inc.
    Date Cleared
    2017-05-17

    (114 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Quantitative Insights, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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