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510(k) Data Aggregation

    K Number
    K052345
    Device Name
    ADVANTAGE SIM MD
    Manufacturer
    Date Cleared
    2005-09-14

    (19 days)

    Product Code
    Regulation Number
    892.5840
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    ADVANTAGE SIM MD

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

    AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR, PET or SPECT studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user to define the target or treatment volume over a defined range of the respiratory cycle.

    The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.

    Device Description

    AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR, PET or SPECT studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle.

    The geometric parameters of a proposed treatment field are selected to allow nondosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.

    The GE Advantage Sim MD has to ensure relations with the following external systems: Data Export, Marking Systems, RT Data Import, Hardcopy, Archiving.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, a specific study, sample sizes, expert involvement, adjudication methods, or multi-reader multi-case studies. The document is a 510(k) summary for the GE Healthcare Advantage Sim MD, outlining its description, indications for use, comparison to predicate devices, and regulatory clearance. It does not include the detailed study information you are requesting.

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