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510(k) Data Aggregation

    K Number
    K051734
    Device Name
    GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955
    Date Cleared
    2005-11-23

    (148 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE HEALTHCARE TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GE Healthcare Navigation and Visualization System [InstaTrak® 3500 Plus System or FluoroTrak™ 9800 Plus System] together with the Axcess™ Bone Pin, is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotaxic surgery and which provides a reference to rigid structures such as sinus, skull, long bone or vertebra visible on medical images such as CT, MR or x-ray, The Axcess™ Bone Pin is to be used where rigid fixation of a tracking device to bone is required.
    Device Description
    The GE Healthcare Navigation and Visualization System [InstaTrak® 3500 Plus System or FluoroTrak™ 9800 Plus System] together with the Axcess™ Bone Pin. The Axcess™ Bone Pin is one example of the Axcess™ Bone Pin.
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    K Number
    K042866
    Device Name
    AMX5 AND AMX5D MOBILE X-RAY SYSTEMS
    Date Cleared
    2004-11-02

    (15 days)

    Product Code
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE HEALTHCARE TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AMX5 and AMX5D are indicated for use in generating radiographic images of human anatomy in all general purpose X-ray diagnostic procedures. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, pediatrics, orthopedics, and clinics.
    Device Description
    The AMX5 is a power driven mobile unit including an X-ray generator, X-ray tube, and beam limiting device, along with control electronics for the drive mechanism, and embedded software. The AMX5D is the same as the AMX5 but is used in conjunction with a portable digital X-ray detector.
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