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

    Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM

    K Number: K102680 · Decision Oct 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    1
    Review Days
    35

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    Basic Information

    Device Name
    Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM
    K Number
    K102680
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Control-X Medical, Inc.
    Date Received
    September 17, 2010
    Decision Date
    October 22, 2010
    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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