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510(k) Data Aggregation

    K Number
    K955774
    Device Name
    VARIS PORTALVISION
    Manufacturer
    VARIAN ASSOC., INC.
    Date Cleared
    1996-03-15

    (85 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VARIS PORTALVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To assist the therapist in verification of the treatment field and shielding blocks in relation to anatomical landmarks in radiotherapy treatment.

    Device Description

    VARiS PortalVision™ is an on-line electronic portal imaging system which allows for verification of the treatment field and shielding blocks in relation to anatomical landmarks in radiotherapy treatment. The imaging mechanism of VARiS PortalVision™ is an ionization chamber.

    VARiS PortalVision™ is fully integrated into Varian's VARiS environment. It is a subsystem of the VARiS Images application. The VARiS PortalVision™ software supports image acquisition, image processing, and image evaluation by means of quantitative comparison tools.

    As a subsystem of VARiS Images, VARiS Portal Vision™ runs on the VARiS Images workstation. The VARiS Images workstation is based on an Intel Pentium processor based PC running Microsoft Windows NT or the Win 95 operating system.

    AI/ML Overview

    The provided text is a K955774 submission for the VARiS PortalVision™ device. It describes the device, its intended use, and technological considerations, but it does not contain information about acceptance criteria, a study proving performance against those criteria, or details regarding ground truth, sample sizes, or expert involvement for assessing performance.

    Therefore, I cannot fulfill your request for:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes used for the test set or data provenance.
    • Number and qualifications of experts for ground truth.
    • Adjudication method.
    • MRMC comparative effectiveness study results.
    • Standalone performance study results.
    • Type of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.

    This document primarily focuses on the device's description, predicate comparison, and intended use as part of a 510(k) submission, which typically outlines the device's functionality and its substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria and clinical results.

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