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510(k) Data Aggregation

    K Number
    K050772
    Device Name
    NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    2005-04-21

    (27 days)

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

    IMAGE-GUIDED NEUROLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: The Navigus Reusable Passive Probe is intended to be used in conjunction with the Navigus family of trajectory guides and the Medtronic StealthStation® Treatment Guidance System for patient registration and navigation.
    Device Description
    Navigus Reusable Passive Probe
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    K Number
    K043091
    Device Name
    NAVIGUS NEXDRIVE, MODEL MI-3000
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    2005-02-07

    (90 days)

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

    IMAGE-GUIDED NEUROLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeXdrive Disposable Micro-drive for use the with FHC microTargeting® Drive System Display and Power Assist Accessories is intended to be used in conjunction with the Navigus™ family of Trajectory Guides for the precise positioning of microelectrodes, stimulating electrodes, implantable electrodes, or other instruments in the brain or nervous system.
    Device Description
    Not Found
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    K Number
    K040334
    Device Name
    NAVIGUS PASSIVE PROBE, MODEL NP-1000
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    2004-10-04

    (236 days)

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

    IMAGE-GUIDED NEUROLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: The Navigus Passive Probe is intended to be used in conjunction with the Navigus family of trajectory guides and the Medtronic StealthStation® Treatment Guidance System for patient registration and navigation. The device is provided sterile and for single use.
    Device Description
    Not Found
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    K Number
    K040834
    Device Name
    NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    2004-06-03

    (64 days)

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

    IMAGE-GUIDED NEUROLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: The Navigus Passive Probe (BL) is intended to be used for trajectory navigation in conjunction with the Navigus family of Image-Guided Systems. The device is provided sterile and for single use.
    Device Description
    Not Found
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    K Number
    K033619
    Device Name
    NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    2004-03-02

    (105 days)

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

    IMAGE-GUIDED NEUROLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Navigus Unibody Fiducial Marker System is intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.
    Device Description
    Not Found
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    K Number
    K031885
    Device Name
    NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    2003-08-21

    (64 days)

    Product Code
    HBL
    Regulation Number
    882.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMAGE-GUIDED NEUROLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: The Navigus Passive Head Restraint System is intended for use in neurosurgical procedures.
    Device Description
    Not Found
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    K Number
    K024201
    Device Name
    NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    2003-03-12

    (82 days)

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

    IMAGE-GUIDED NEUROLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Navigus Fiducial Marker System is intended to provide fixed reference point(s) in patients requiring stereotactic provide The device is provided sterile and is for one time use only.
    Device Description
    Not Found
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    K Number
    K023949
    Device Name
    NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    2003-02-25

    (90 days)

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

    IMAGE-GUIDED NEUROLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: The Navigus II Trajectory Guide with Verification Reticules is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of an Image Guided Workstation System using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction. The device is ETO sterilized and for one time use.
    Device Description
    Not Found
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    K Number
    K022100
    Device Name
    NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    2002-09-25

    (89 days)

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

    IMAGE-GUIDED NEUROLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: The Manual Disposable Micro-drive with Digital Display is intended to be used in conjunction with the Navigus™ family of Trajectory Guides for the precise positioning of microelectrodes, stimulating electrodes, implantable electrodes, or other instruments in the brain or nervous system.
    Device Description
    Not Found
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    K Number
    K012719
    Device Name
    NAVIGUS II MR
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    2001-10-22

    (69 days)

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

    IMAGE-GUIDED NEUROLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: The NAVIGUS II MR Trajectory Guide is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The Trajectory Guide is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode introduction. This device will provide accurate delivery of devices or instruments to target sites 3mm and larger.
    Device Description
    Not Found
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