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510(k) Data Aggregation

    K Number
    K101042
    Device Name
    BLADEVIEW
    Manufacturer
    ACCOGENT LLC
    Date Cleared
    2010-10-29

    (198 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCOGENT LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BladeView is a full featured Radiographic Flat-Panel Digital Imaging System. It Is intended to replace conventional film screen systems. The BiadeView allows a qualified operator to perform digital radiographic examinations of various anatomic regions on both adult and pediatric patients. Anatomic regions of interest for diagnostic radiographic exposure include: skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremittee. The BladeView enables a qualified operator to acquire, process, and display images. The BladeView system enables the qualified operator to store, hardcopy images with a laser printer or send images over a network. This device is not intended for mammographic, fluoroscopic and or anglographic applications.
    Device Description
    The BladeView is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The main configuration includes a portable X-ray detector, generator, workstation and various other allied parts and components necessary for radiographic studies. It is also configurable to be used in an existing conventional radiographic room (Film or CR) and only the Flat panel and workstation would be needed. The system has medications ranging from but not limited to cranial, skeletal, thoracic and lung exposures as well as examination of the extremities.
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