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510(k) Data Aggregation

    K Number
    K193317
    Device Name
    CoreLite X-Ray Specimen Cabinet
    Manufacturer
    Cirdan Imaging Limited
    Date Cleared
    2019-12-13

    (14 days)

    Product Code
    MWP
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cirdan Imaging Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CoreLite device is a cabinet X-ray system used to provide digital X-ray images of specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure. Performing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.
    Device Description
    The CoreLite Specimen Radiography System is a self-contained digital imaging system for verification of breast biopsy specimens at the point of care which enables the procedure to be completed faster. The system is comprised of the x-ray cabinet and the PC with DICOM compliant software which provides the user interface, means to enter patient details (either directly or from a DICOM Modality Worklist, if available) and the means to acquire, review and save or transmit DICOM images to the Picture Archiving and Communication System (PACS). The cabinet incorporates shielding and interlock circuits to meet requlatory requirements.
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