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

    Diagnostic X-ray System

    K Number: K150663 · Decision May 7, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    6
    Review Days
    52

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    Basic Information

    Device Name
    Diagnostic X-ray System
    K Number
    K150663
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osko, Inc.
    Date Received
    March 16, 2015
    Decision Date
    May 7, 2015
    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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