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510(k) Data Aggregation

    K Number
    K231690
    Device Name
    iCAS-LV
    Manufacturer
    Date Cleared
    2024-03-01

    (266 days)

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

    HighRAD Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iCAS -LV is intended to receive multi-phase volume datasets of reconstructed studies from PACS devices, to process them and to transfer the processing output to the PACS in DICOM format. It is a PC-based, self-contained, noninvasive image analysis software application. The device provides tools for visualization, measurements, segmentation, annotation, images registration, processing, and reporting. The device is intended for use by trained physicians. Further, the iCAS-LV is indicated to support the physicians in visualization of CT reconstructed images and evaluation of physician-identified liver lesions. The combination of the visualization, interactive segmentation, measurements, automatic registration, and volumetric analysis, supports the physician in evaluation of the lesions in terms of size, shape, position and changes over time. The iCAS should not be used in isolation for diagnosis and making patient management decisions.
    Device Description
    The iCAS-LV (iCAS hereafter) provides tools for interactive segmentation of radiologist-identified liver lesions, automatic lesion length (diameter) and lesion volume computation, supervised automatic liver registration of the prior and current contrast-enhanced CT (ceCT scans, henceforth CT scans), semiautomatic lesions matching between two scans, and automatic lesion length (diameter) and volume change over time computation. These software tools will enable the user to easily assess the individual lesions volume and length (diameter), the total lesions burden volume and their evolution over time. This may help save radiologists and clinicians significant time and effort and improve the comprehensiveness and reliability of their reporting. The processing of the CT scans by iCAS does not rely on nor use any CT scanner-specific data. The device is compatible with CT scanners of vendors and models that conform to DICOM requirements as specified in the device Labeling. The output is a quantitative analysis of the liver lesions volumes and their locations in the prior and current CT scans and a quantitative analysis of the volumetric changes of these lesions over time. The pipeline process consists then of two validation/manual steps and four automatic steps as follows: - 1) Generate liver ROI of both Prior and Current scans. - 2) Registration of liver ROls using deformable registration. - 3) Lesion segmentation using 3D U-Net models. Segmentations are not displayed to the user until lesions are identified in Step 4 - 4) Designation of the liver lesions by the radiologist in both prior and current scans, with the selection and validation of their computed segmentations, including, when needed, manual correction of these computed lesion segmentations. - 5) Semi-automatic lesion matching of the identified lesions in the Prior and Current CT scans, including Labeling the lesions as existing, new or disappeared. - 6) Lesions and lesions change quantification (volume and diameter), which can be extended to a complete longitudinal CT study analysis. The technique computes various quantitative lesion change measures and identifies key slices in each scan.
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