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510(k) Data Aggregation

    K Number
    K083591
    Device Name
    IKOENGELO, VERSION 2
    Manufacturer
    IKOETECH, LLC.
    Date Cleared
    2008-12-29

    (25 days)

    Product Code
    KPQ
    Regulation Number
    892.5840
    Why did this record match?
    Applicant Name (Manufacturer) :

    IKOETECH, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IKOEngelo™ System is indicated for use by radiation oncologists, medical physicists, and medical dosimetrists for tumor and normal tissue contour delineation to support the radiotherapy treatment planning process. The resulting information may then be exported to a treatment planning system for dose calculation.
    Device Description
    The IKOEngelo version 2.0 device is a software system upgraded from version 1.0. This submitted new version has better contour modification tool, faster image files loading and display, and a new function for image fusion. For the same purpose of version 1.0, this software will assist radiation oncologists with the assistance of physicists and dosimetrists to more efficiently perform contour delineation of the tumor target and normal tissue on patient's CT images.
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    K Number
    K061006
    Device Name
    IKOENGELO
    Manufacturer
    IKOETECH, LLC.
    Date Cleared
    2006-06-05

    (55 days)

    Product Code
    KPQ, IYE, MUJ
    Regulation Number
    892.5840
    Why did this record match?
    Applicant Name (Manufacturer) :

    IKOETECH, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IKOEngelo™ System is intended for use in tumor and normal tissue contour delineation to support the radiotherapy treatment planning process. The IKOEngelo™ System is indicated for use by radiation oncologists, medical physicists, and medical dosimetrists for tumor and normal tissue contour delineation to support the radiotherapy treatment planning process. The resulting information may then be exported to a treatment planning system for dose calculation.
    Device Description
    The IKOEngelo device is a software system that will assist radiation oncologists, with the assistance of physicists and dosimetrists, to more efficiently perform contour delineation of the tumor target and normal tissue on patient's CT images. The sequence of events is illustrated in the following bullet items and diagram: - Import patient's CT images. . - Select the proper Expert Case (including the CT image data set and . contours) to match patient's CT. - Automatically fuse the images to align patient's CT image data sets . with those of the Expert Case. - Run deformable segmentation to auto-contour on the patient's CT . images. - Review patient's contours and modify them if necessary. . - Approval by qualified radiation oncologist. . - Export patient's CT with its contours to the treatment planning system . used by the facility.
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