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510(k) Data Aggregation

    K Number
    K190064
    Device Name
    nView system 1
    Manufacturer
    nView medical, Inc.
    Date Cleared
    2019-07-08

    (174 days)

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

    nView medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    nView system 1 is intended to provide both 2D and 3D imaging of adult and pediatric populations over 6 years of age. The device is intended to provide fluoroscopic and tomographic imaging of patients during orthopedic surgical procedures where the clinician benefits from 3D visualization of complex anatomical structures, such as high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities. The device is indicated to image human anatomy up to 30 cm thickness. The device is not indicated for mammographic or lung nodule applications.
    Device Description
    The nView system 1 mobile fluoroscopic system is cone beam computed tomography X-ray system and a fluoroscopic X-ray imaging system consisting of two mobile units: a mobile C-arm and a monitor cart. The mobile C-arm is comprised of a fixed anode X-ray tube, a high voltage generator, X-ray controls, and a mechanical "C" shaped structure which supports the X-ray tube and generator and the image receptor flat panel detector. The monitor cart is a mobile platform that connects to the mobile C-arm by USB and HDMI cables, and which integrates the flat panel display monitors and user controls. The nView system 1 employs X-rays as its imaging technology for visualizing human anatomy in both 2D and 3D. The X-ray tube powered by a generator produces X-rays, which image the patient under control of the user, at the direction of a physician. The images from the system assist the physicians in visualizing the patient's anatomy during surgical procedures. The device provides both real-time image capture visualization suitable for use both during surgery or immediately pre or post-surgery. The device performs both 2D and 3D medical imaging generated by means of an iterative algorithm. The system uses the images of a scan captured with relation to a predefined scan reference frame to compute the three-dimensional representation of the imaged object. The images are displayed on the screen of the monitor cart. It is possible to display projection views as well as orthogonal tomographic views.
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