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510(k) Data Aggregation

    K Number
    K030544
    Device Name
    RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM
    Manufacturer
    SIGMA VISION, INC.
    Date Cleared
    2003-05-21

    (90 days)

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

    SIGMA VISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RFX Fluoroscopic digital imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.
    Device Description
    The RFX fluoroscopic digital imaging system allows the use of digital imaging to be applied to conventional X-ray system used in general fluoroscopy, interventional fluoroscopy, angiography and cardiac imaging areas. The system works by installing a CCD camera on the output port of the imaging intensifier and digitizing the video output of the image intensifier. The digital image can be displayed on the monitor; it can be stored to the hard drive, or sent to an external device such as a laser imager or Dicom Network Service Provider. The image can also be processed, including brightness and contrast, edge enhancement, zoom, and subtraction.
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