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510(k) Data Aggregation

    K Number
    K983660
    Device Name
    EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)
    Manufacturer
    BRAINLAB, INC.
    Date Cleared
    1999-07-14

    (268 days)

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

    BRAINLAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This submission describes a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures.
    Device Description
    The ExacTrac System uses optical tracking of infrared reflecting markers as the method of locating the position of the patient. The ExacTrac System consists of infrared cameras, computer workstation, reflective markers and calibration tools.
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    K Number
    K962939
    Device Name
    VECTORVISION
    Manufacturer
    BRAINLAB, INC.
    Date Cleared
    1997-05-22

    (297 days)

    Product Code
    HAW, 84H
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAINLAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Frameless stereotactic cranial neurosurgery and intraoperative would be surgical guidance.
    Device Description
    Not Found
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