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510(k) Data Aggregation

    K Number
    K143485
    Device Name
    iGuide 2.1
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Date Cleared
    2015-03-04

    (86 days)

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

    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH

    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 2.1 System is a powered radiation therapy support assembly which provides patient positioning control prior to radiotherapy treatment. iGUIDE 2.1 System consists of the iGUIDE workstation with software, a tracking system, reference frame, calibration tool, isolation transformer, KVM Extender and monitors for the workstation and terminal. The iGUIDE software controls the combined working of the HexaPOD evo RT System components and provides status detection via the software GUI to the user. The HexaPOD evo RT System consists of iGUIDE and the HexaPOD evo RT Couchtop, a robotic patient-positioning platform with six degrees of freedom, which is cleared under K072898.
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    K Number
    K121530
    Device Name
    BODYFIX SYSTEM
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Date Cleared
    2012-06-20

    (27 days)

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

    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended to be used by radiologists and surgeons for the following: . Patient positioning and immobilization - Stereotactic diagnostic localization . - Patient positioning and immobilization device for . stereotactic radiotherapy of extracranial targets
    Device Description
    The BodyFIX System is a patient positioning and immobilization device for use with radiotherapy, radiosurgery, sonography, surgery/CAS, imaging neurosurgery and brachytherapy treatments of extracranial targets. The principal parts of the system include the vacuum cushion, cover sheet, vacuum supply (vacuum pump), target positioner and localizer, and carbon fiber baseplate. The BodyFIX Vacuum Pump P3 is a high-performance vacuum pump that contains two separate pumps; the BlueBAG pump and the BodyFIX pump. - 1- BlueBAG pump provides the vacuum for inflating, forming and deflating the BlueBAG vacuum cushions.
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    K Number
    K112210
    Device Name
    FRAXION
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Date Cleared
    2011-11-22

    (113 days)

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

    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fraxion™ is intended to be used for immobilisation, positioning and re-positioning during Stereotactic Radiotherapy (SRT) in all parts of the brain and head in a Linear Accelerator environment. Further Fraxion™ is used to immobilise and position the head during image acquisition to support treatment planning. Under certain circumstances (e.g. when the patient will not tolerate an invasive frame) Fraxion™ may also be used for Stereotectic Radiosurgery (SRS) in a Linear Accelerator environment.
    Device Description
    Fraxion™ is a device for cranial stereotactic radiotherapy and radiosurgery. The major parts of the system include the Fraxion frame, Patient Control Unit, Frontpiece incl. Mouthpiece, vacuum cushion, thermoplastic mask and Stereotactic Frame.
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    K Number
    K072898
    Device Name
    HEXAPOD EVO RT COUCH TOP
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Date Cleared
    2007-10-25

    (14 days)

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

    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH

    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 evo consists of two platforms, which are connected by six 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
    K071870
    Device Name
    HEXAPOD RT COUCH TOP
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Date Cleared
    2007-07-08

    (2 days)

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

    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH

    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
    K041448
    Device Name
    HEXAPOD RT COUCHTOP
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Date Cleared
    2004-06-16

    (15 days)

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

    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH

    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 teach pad. Additionally it can be directed via an external graphics user interface (GUI) which is installed on a PC.
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    K Number
    K030439
    Device Name
    HEADFIX
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Date Cleared
    2003-05-08

    (86 days)

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

    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Positioning and repositioning of the patient's head; Stereotactic diagnostic localization; and Stereotactic radiotherapy of cranial targets
    Device Description
    The VBH HeadFIX™ is a fixation device for cranial stereotactic radiotherapy and radiosurgery. The major parts of the system include the Vacuum Pump, Vacuum Cushion, Target Positioner Screens and Baseplate, Post Set, and Cranial Localizer.
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    K Number
    K013391
    Device Name
    BODYFIX
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Date Cleared
    2002-01-11

    (88 days)

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

    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for use by radiologists and surgeons for: - Patient positioning and immobilization - Stereotactic diagnostic localization - Stereotactic radiotherapy of extracranial targets
    Device Description
    The BodyFIX system is a patient positioning and immobilization device for use with radiotherapy, radiosurgery, sonography, surgery/CAS, imaging neurosurgery and brachytherapy treatments of extracranial targets. The five principal parts of the system include the vacuum cushion, fixation sheet, vacuum supply, target positioner and localizer, and carbon fiber baseplate.
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