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

    RADKOR TS10-B

    K Number: K892196 · Decision Apr 26, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    26
    Applicant Total
    10
    Review Days
    23

    Basic Information

    Device Name
    RADKOR TS10-B
    K Number
    K892196
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1980
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    RADKOR, INC.
    Date Received
    April 3, 1989
    Decision Date
    April 26, 1989
    Product Code
    IXQ
    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
    IXQ Table, Radiographic, Stationary Top

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