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510(k) Data Aggregation

    K Number
    K142243
    Device Name
    LessRay with Tracking
    Manufacturer
    SAFERAY SPINE, LLC
    Date Cleared
    2014-11-18

    (97 days)

    Product Code
    OWB, JAA, LLZ
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAFERAY SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LessRay® with Tracking is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
    Device Description
    LessRay is a software application which can be interfaced to a fluoroscope with a video cable. The images produced by the fluoroscope are transmitted to a frame grabber in the computer running LessRay® where the images are enhanced and then displayed. When used in connection with the low dose and/or pulse setting on the fluoroscope, the user can improve the quality (clarity, contrast, noise level, and usability') of a noisy (low-quality) image. Using this system, much of the graininess of low radiation dose images can be eliminated. This allows for greater utility of low dose imaging. - LessRay® works by combining the current image being taken with a prior "Baseline" image of the same anatomy. The initial image, taken at regular radiation dose settings, serves as a baseline to which images taken at lower dose radiation settings can be compared and enhanced. In procedures where instruments are introduced into the field of view, LessRay® images provide information that is not available with conventional images. By merging an image of interest containing tools with the unencumbered Baseline image, the radio dense metallic tools and implants that obscure the underlying anatomy can be rendered partially translucent in the merged image. In addition, by alternating the new image with the Baseline a user can make these metallic tools or implants disappear and reappear from the image, revealing the anatomy blocked by the tool. The subject of this 510(k) is the addition of tracking capability to be used with LessRay LessRay can be interfaced with a tracking system in order to aid the C-arm technician in positioning the fluoroscope between the various views of the patient necessary for the intervention. LessRay® with Tracking ensures that the fluoroscope is centered over the correct anatomy prior to taking any additional x-ray images.
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    K Number
    K132970
    Device Name
    LESSRAY
    Manufacturer
    SAFERAY SPINE, LLC
    Date Cleared
    2013-11-29

    (67 days)

    Product Code
    OWB, LLZ
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAFERAY SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LessRay® is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
    Device Description
    I.essRay* is a software only device that is used to enhance the utility of low dose images by comparing them to a baseline image taken at a regular dose setting. A computer running LessRay" is interfaced to a fluoroscope with a video cable. The images produced by the fluoroscope are transmitted to a frame grabber in the computer where the images are enhanced and then displayed on the monitor of the computer running LessRay®. Each image is displayed by LessRay at the same time as the corresponding original image is displayed on the fluoroscope monitor(s).
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    K Number
    K123226
    Device Name
    LESSRAY
    Manufacturer
    SAFERAY SPINE, LLC
    Date Cleared
    2012-12-05

    (51 days)

    Product Code
    OWB, LLZ
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAFERAY SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LessRay™ is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
    Device Description
    The LessRay™ is a stand-alone computer display system interfaced to a fluoroscope with a video cable. The images produced by the fluoroscope are transmitted to a frame grabber in the computer where the images are enhanced and then displayed on the LessRay™ monitor. Each image is displayed on the LessRay™ monitor at the same time as the corresponding original image is displayed on the fluoroscope monitor(s).
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