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510(k) Data Aggregation

    K Number
    K083423
    Device Name
    COLONCAD API 3.1
    Manufacturer
    MEDICSIGHT PLC
    Date Cleared
    2011-05-17

    (909 days)

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

    MEDICSIGHT PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medicsight ColonCAD™ API is a non-invasive computer aided detection (CAD) image analysis software tool designed to assist radiologists in the detection of colorectal polyps during their review of digital images derived from CT colonography (CTC). This CAD software post-processes the CTC image data obtained from multi-detector computed tomography (MDCT) scanners. The device is intended to be used on patients referred for a CT Colonography examination, as an overlay tool to prompt the radiologist to colonic findings that have been identified by the device. The CAD can assist radiologists after they have made an initial review of all the CTC image data, supporting their evaluation ("second read").
    Device Description
    Medicsight ColonCAD API is a medical imaging software tool designed to assist radiologists in the detection of polyps in CT scans of the product is packaged as an Application Programming Interface (API) which allows it to be integrated into existing medical imaging solutions. The ColonCAD API assists the radiologist in detecting colorectal polyps using mathematical image processing techniques. The CAD assists the radiologist by highlighting potential polyps in 2D and 3D image views. The results are displayed in the form of "CAD marks" on or near the potential polyps. The radiologist must assess every CT scan image to search for polyps and review the CAD marked images to determine if the indicated findings are polyps. Patient management decisions should not be made solely on the results of ColonCAD analysis.
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