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

    A.X.T. SPOTFILM DEVICE

    K Number: K882492 · Decision Jul 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    12
    Applicant Total
    3
    Review Days
    35

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    Basic Information

    Device Name
    A.X.T. SPOTFILM DEVICE
    K Number
    K882492
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1670
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Applied X-Ray Technologies, Inc.
    Date Received
    June 16, 1988
    Decision Date
    July 21, 1988
    Product Code
    IXL
    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
    IXL Device, Spot-Film

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