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510(k) Data Aggregation

    K Number
    K210916
    Device Name
    PVmed Contouring Software
    Date Cleared
    2021-12-03

    (249 days)

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

    Perception Vision Medical Technologies LTD.CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PV med Contouring Software is a software package. It allows the display, annotation, volume operation, volume rendering, and fusion of medical CT images as an aid during use by radiation therapy planning. it is limited to autocontouring of OARs for head and neck, chest and abdomen, abdomen and pelvis.
    Device Description
    The device, PVmed Contouring Software is a software package. It allows the display, annotation, volume operation, volume rendering, and fusion of medical CT images as an aid during use by radiation therapy planning. it is limited to auto-contouring of OARs for head and neck, chest and abdomen, abdomen and pelvis. The product mainly has the following image processing functions: Support contour drawing of organs at risk in head and neck, chest and abdomen, abdomen and pelvis. It also has the following general functions: - Receive, add/edit/delete, transmit, input/export, medical images and DICOM data; - Data set management, patient data management; - Review of processed images; - Image fusion; - Open and Save of files.
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