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510(k) Data Aggregation

    K Number
    K072079
    Device Name
    IGUIDE SYSTEM
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA
    Date Cleared
    2007-08-14

    (15 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.
    Device Description
    The iGUIDE System is a powered radiation therapy support assembly which provides patient positioning control before radiotherapy treatment. The iGUIDE System consists of the following system components: iGUIDE Reference Frame with optical markers, iGUIDE Calibration Phantom (calibration phantom for KV-imaginq). NDI Polaris Tracking System, iGUIDE Workstation with iGUIDE software (control room) and iGUIDE Terminal (treatment room). The iGUIDE System is intended to be used together with the HexaPOD RT CouchTop (k041448), which is intended to be used together with the following radiation therapy systems: Elektra Precise Treatment System with Precise Table (k983678), Varian Trilogy Radiotherapy Delivery System (k033343), Clinac 2300 C/D with Exact Couch (K913119),and Siemens PRIMUS or ONCOR Linear Accelerator with Siemens ZXT Treatment Table (k910971)
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    K Number
    K062639
    Device Name
    MODIFICATION TO HEXAPOD RT COUCH TOP
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA
    Date Cleared
    2006-09-21

    (15 days)

    Product Code
    JAI
    Regulation Number
    892.5770
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device is to support and aid in positioning a patient during radiation therapy.
    Device Description
    The HexaPOD consists of two platforms, which are connected by six linear, rigid but length adjustable elements which are powered. By appropriate coordinative adjustment of these elements, the system is able to move the upper platform relative to the lower one. The movement can occur in all three dimensions in space. Additionally the upper platform can rotate around these three axes which results in a tilt or a rotation of the upper platform relative to the lower one. Finally an accurate positioning within all six degrees of freedom (6DOF) can be provided. The HexaPOD consists of a controller unit which is directed by a cable connected hand control. Additionally it can be directed via an external graphics user interface (GUI) which is installed on a PC.
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    K Number
    K062611
    Device Name
    IGUIDE SYSTEM
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA
    Date Cleared
    2006-09-20

    (15 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment
    Device Description
    The iGUIDE® System controls the movement of the Medical Intelligence HexaPOD™ RT CouchTop (K041448), a radiographic treatment table with 6 DOFs (Degrees of freedom). With the integrated 3D Tracking System the device controls also the accuracy of the patient positioning. The iGUIDE® System consists of a PC workstation, a graphics user interface to the treatment table (software) and the NDI Polaris 3D Tracking System. The iGUIDE® System is integrated into radiation therapy systems of Elekta, Varian, and Siemens and is connected to them with an Interlock connection.
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