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510(k) Data Aggregation

    K Number
    K030745
    Device Name
    GAMMAMED 212 AND 232 SOURCE ASSEMBLY
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Date Cleared
    2003-03-12

    (2 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K891131
    Why did this record match?
    Device Name :

    GAMMAMED 212 AND 232 SOURCE ASSEMBLY

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

    The Gammamed Model 212 and 232 source assembly is designed to be used in conditions typically associated with hospitals and medical facilities for the treatment of cancerous tumors.

    Device Description

    The Gammamed 212 and 232 Source Assemblies are brachytherapy sources that are used in conjunction with Gammamed remote afterloaders. The Gammamed 212 Source Assembly is used in conjunction with the Gammamed 12i or 12it temote afterloader. The Gammamed 232 Source Assembly is used with either the Gammamed Plus or Gammamed 3/24 afterloader.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) premarket notification for the Gammamed 212 and 232 Source Assembly, focusing on administrative details, device description, and a comparison to a substantially equivalent device. It details the regulatory approval process but does not include clinical study data or performance metrics. Therefore, I cannot generate the requested table and accompanying study information.

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