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510(k) Data Aggregation

    K Number
    K192939
    Device Name
    Volumetric Specimen Imager
    Manufacturer
    Clarix Imaging
    Date Cleared
    2019-12-27

    (70 days)

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

    Clarix Imaging

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Volumetric Specimen Imager is a Cabinet x-ray system that is used to provide two and three dimensional digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.
    Device Description
    The Clarix Imaging Volumetric Specimen Imager (VSI) is a portable, fully shielded cabinet X-ray system that provides high resolution 2D and 3D radiographic images of surgically excised specimens. The VSI system consists of an image-acquisition device and software for image reconstruction, visualization, and archival. Enabled by optimized imaging geometry and iterative image reconstruction algorithm, VSI provides superior spatial and contrast resolution for visualizing specimens with soft tissues or boney structures. VSI is designed to comply with 21 CFR 1020.40 and DICOM standards.
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