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

    XRT 400

    K Number: K955414 · Decision Jul 24, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    30
    Applicant Total
    9
    Review Days
    240

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    Basic Information

    Device Name
    XRT 400
    K Number
    K955414
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1980
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wuestec Medical, Inc.
    Date Received
    November 27, 1995
    Decision Date
    July 24, 1996
    Product Code
    KXJ
    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
    KXJ Table, Radiologic

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