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510(k) Data Aggregation

    K Number
    K964229
    Device Name
    REGULUS NAVIGATOR
    Manufacturer
    COMPASS INTL., INC.
    Date Cleared
    1997-08-19

    (300 days)

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

    COMPASS INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intraoperative Guidance Device to Localize a Surgical Field for Intra/Extracranial Usage
    Device Description
    The Regulus Navigator (RN) incorporates preoperative CT and MRI images into a surgical computer system. A minimum of three points (reference markers or anatomical points) are selected with the RN on the patient in the operating room (OR space) and the corresponding locations on the images (image space) are determined and selected by the surgeon. These corresponding points in the OR space and the image space are utilized to calculate a "transformation matrix" which is used to transform the location of the RN instrument into the image space. The location of the RN instrument is interactively displayed as a cursor on the diagnostic images and then used as a tool to guide the surgeon during the intra/extracranial procedure.
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