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510(k) Data Aggregation

    K Number
    K023227
    Device Name
    USG 2000SA
    Manufacturer
    ULTRAGUIDE LTD.
    Date Cleared
    2002-10-22

    (25 days)

    Product Code
    HHJ
    Regulation Number
    884.2225
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRAGUIDE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UltraGuide USG 2000sa system is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle or an aspiration needle, and for predicting its future path. The enhancement and prediction are presented on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in clinical applications and for anatomical structures where ultrasound is currently used for visualizing such procedures.
    Device Description
    The UltraGuide USG 2000sa provides visual enhancement of the interventional needle by overlaying the image of the insertion device and its predicted future path on the ultrasound scan image of the internal organs, all displayed on the monitor of a personal computer. The device uses magnetic transmitters and receivers, sold under the trade name "PC Birds," to determine the location and orientation of the interventional needle. These devices have been used on medical devices cleared by the FDA. The positions and orientations of the interventional device and the video of the US image, are transmitted to a Personal Computer, which makes the necessary calculations to provide the overlay of the video image and the interventional device.
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    K Number
    K022354
    Device Name
    ULTRAGUIDE CTG 2000SA
    Manufacturer
    ULTRAGUIDE LTD.
    Date Cleared
    2002-08-13

    (25 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRAGUIDE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CTG 2000sa system is a stereotactic accessory for Computed Tomography (CT) systems. It displays the simulated image of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the CT image of the target organs and the projected future path of the interventional instrument, compensating for respiratory movements of the patient. The device is intended to be used in clinical applications and for anatomical structures where computed tomography is currently used for visualizing such procedures.
    Device Description
    The CTG 2000sa provides visual enhancement of the interventional needle by overlaying the image of the insertion device and its predicted future path on the CT image of the internal organs, all displayed on the monitor of a personal computer. The device uses magnetic transmitters and receivers, sold under the trade name "PC Birds," to determine the location and orientation of the interventional needle. These devices have been used on medical devices cleared by the FDA. The positions and orientations of the interventional device, and the video of the CT image, are transmitted to a Personal Computer, which makes the necessary calculations to provide the overlay of the video image and the interventional device.
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    K Number
    K013150
    Device Name
    MR-GUIDE 2000
    Manufacturer
    ULTRAGUIDE LTD.
    Date Cleared
    2001-10-18

    (28 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRAGUIDE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MR-Guide 2000 system is a frameless stereotactic guiding accessory for Magnetic Resonance (MR) systems. The system is MRI-compatible. It displays the simulated image of a rigid insertion instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the MR image of the target organs and the projected future path of the interventional instrument, compensating for respiratory movements of the patient. The device is intended to be used in clinical interventions and for anatomical structures where magnetic resonance is currently used for visualizing such structures.
    Device Description
    The MR-Guide 2000 provides visual guiding information of the interventional instrument by overlaying graphics depicting its relative position and its predicted future path on the MR image of the internal organs all displayed on the monitor of a personal computer.
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    K Number
    K011418
    Device Name
    ULTRAGUIDE MR-GUIDE 3000
    Manufacturer
    ULTRAGUIDE LTD.
    Date Cleared
    2001-05-24

    (15 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRAGUIDE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002258
    Device Name
    ULTRAGUIDE CT-GUIDE 1010
    Manufacturer
    ULTRAGUIDE LTD.
    Date Cleared
    2000-08-08

    (14 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRAGUIDE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K974432
    Device Name
    ULTRAGUIDE 1000
    Manufacturer
    ULTRAGUIDE LTD.
    Date Cleared
    1998-02-09

    (77 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRAGUIDE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UltraGuide 1000 system is indicated for enhancing the ultrasonic image of an interventional needle or needlelike rigid device, such as a biopsy needle or an aspiration needle, and for predicting its future path. The enhancement and prediction are presented on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in clinical applications and for anatomical structures where ultrasound is currently used for visualizing such procedures.
    Device Description
    The UltraGuide 1000 provides visual enhancement of the interventional needle by overlaying the image of insertion device and its predicted future path on the insertion action and of the internal organs, all displayed on the monitor of a personal computer. The device uses magnetic transmitters and receivers, sold under the trade name "MiniBirds," to determine the location and orientation of the ultrasound scan head and the interventional needle. The positions and orientations of the interventional device, and the video of the ultrasound image, are transmitted to a Personal Computer, which makes the necessary calculations to provide the overlay of the video image and the interventional device.
    Ask a Question

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