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510(k) Data Aggregation

    K Number
    K981898
    Device Name
    ORTHOVU-1000
    Manufacturer
    Date Cleared
    1998-08-03

    (63 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAGNEVU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OrthoVu-1000 is intended to produce MRI images of human extremities, which when reviewed by a qualified medical practitioner, can render medical information of the region under review.
    Device Description
    The OrthoVu-1000 is a transportable, permanent-magnet MRI system, which uses a surface magnet/coil assembly to perform nuclear magnetic resonance imaging of human anatomy with particular emphasis on the imaging of extremities. This system utilizes a non-homogeneous magnetic field, developed by a single device head, which applies magnetic and radio frequency (RF) energy and then detects the resultant spin echoes. A computer system controls excitation and performs processing and imaging functions. The control and imaging computer as well as the associated electronics package is mounted on a cart with a magnet assembly which can be manually positioned in the correct orientation to perform the desired imaging.
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