BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    QV-9000 UNIVERSAL SYSTEM

    K Number: K083181 · Decision Nov 26, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    5
    Review Days
    29

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    Basic Information

    Device Name
    QV-9000 UNIVERSAL SYSTEM
    K Number
    K083181
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quantum Medical Imaging, LLC
    Date Received
    October 28, 2008
    Decision Date
    November 26, 2008
    Product Code
    KPR
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KPR System, X-Ray, Stationary

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    Other Clearances by Quantum Medical Imaging, LLC

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