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510(k) Data Aggregation

    K Number
    K081073
    Device Name
    HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F
    Manufacturer
    PAUSCH LLC
    Date Cleared
    2008-12-05

    (234 days)

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

    PAUSCH LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HDR Vision is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general RIF, angiography and pediativ examinations. The HDR Vision is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastroninal examinations, cramil, skeletal, procecc and hing exposures as well as examination of the units may also be used in lymphography, endocony, myelography, venggraphy, pediatrics, arthrography, interventional radiology, digital angiocraphy and digital subtaction angiography (DSA). HDR Vision may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.
    Device Description
    The HDR Vision is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. The HDR Vision is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). HDR Vision is a universal fluoroscopic x-ray diagnostic system (RIF system), with an overtable X-ray tube assembly. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. HDR Vision can be configured as a single tube system, with only an overtable tube or it can be combined with an additional 3D overhead tube crane, that can be moved longitudinally and laterally as well as vertically and a bucky wall stand. This device employs similar materials and processes as found in the predicate device. The device produces ionizing radiation that is employed to generate radiographic and fluoroscopic images of the anatomy. HDR Vision is not a stand-alone device, but functions as the platform for specific X-ray components, X-ray tube and housing, flat detector, digital imaging system, Bucky wall stand, collimator, generator etc. Many of the components used in HDR Vision are either commercially available with current Pausch systems or include minor modifications to existing components.
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