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510(k) Data Aggregation

    K Number
    K213691
    Device Name
    Solas OR
    Manufacturer
    Cirdan Imaging Ltd
    Date Cleared
    2021-12-22

    (29 days)

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

    Cirdan Imaging Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Solas OR is a cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification in the same room as the procedure or nearby improves workflow, the time the patient needs to be under examination.
    Device Description
    The Solas OR cabinet x-ray system is a self-contained, direct-detection digital imaging system for imaging small to medium surgical and biopsy specimens. The system is comprised of the x-ray cabinet, optional cart and the PC with DICOM compliant software which provides the user interface, the 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 regulatory requirements. The cabinet cart is mounted on casters to allow for easy transportation. Specimen radiography units are utilized to confirm removal of the intended tissue, lesion, or site marker in surgical and core biopsy specimens from various anatomical regions. By generating a high-resolution x-ray image of the specimen, the presence of a lesion, marker or calcification in the extracted sample can be confirmed by the user reviewing the digital image.
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