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510(k) Data Aggregation

    K Number
    K072529
    Device Name
    TRACKPORT
    Manufacturer
    DIREX SYSTEMS CORP.
    Date Cleared
    2007-10-26

    (49 days)

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

    TRACKPORT

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

    TrackPort is an online EPID intended to aid in target-to-beam relative positioning for administration of radiotherapy. It is indicated for all body procedures and operable in conjunction with TrackLeaf Micro Multi Leaf Collimating (MMLC) system

    Device Description

    TrackPort

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Direx Systems Corp. regarding their device, TrackPort. This document confirms substantial equivalence but does not contain information about the acceptance criteria or a study proving the device meets those criteria. It primarily focuses on the regulatory approval and indications for use.

    Therefore, I cannot extract the requested information based on the provided text.

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