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510(k) Data Aggregation

    K Number
    K060344
    Device Name
    O-ARM IMAGING SYSTEM
    Manufacturer
    BREAKAWAY IMAGING, LLC
    Date Cleared
    2006-03-29

    (47 days)

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

    BREAKAWAY IMAGING, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The O-arm™ Imaging System is designed for 2D fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications. The O-arm™ Imaging System is compatible with certain Image Guided Surgical Systems.
    Device Description
    The O-arm™ Imaging System is a mobile x-ray system which provides 3D imaging as well as 2D fluoroscopic imaging. The system consists of two parts: the x-ray O-arm™ Stand (comprising x-ray generator, flat dynamic x-ray detector, and the x-ray control user interface) and the mobile view station (comprising the image processors, a user interface for image and patient handling, and viewing monitors). The 1-D Display Control Mouse is an optional accessory. It is a sterile disposable limited-function wireless mouse. With the 1-D Mouse, a surgeon can remotely control and point at the O-arm™ image display. The 1-D mouse is similar to remote controls for controlling projectors during business presentations. The 1-D Mouse allows the surgeon to control what is displayed and to point out features on the image with a laser pointer.
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    K Number
    K050996
    Device Name
    O-ARM IMAGING SYSTEM
    Manufacturer
    BREAKAWAY IMAGING, LLC
    Date Cleared
    2005-05-05

    (15 days)

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

    BREAKAWAY IMAGING, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The O-Arm™ Imaging System is designed for 2D Fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications. The O-Arm™ Imaging System is compatible with certain Image Guided Surgery Systems.
    Device Description
    The O-Arm™ Imaging System is a mobile x-ray system which provides 3D imaging as well as 2D fluoroscopic imaging. The system consists of two parts: the x-ray O-Arm™ Stand (comprising x-ray generator, flat dynamic x-ray detector, and the x-ray control user interface) and the mobile view station (comprising the image processors, a user interface for image and patient handling, and viewing monitors).
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