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

    TRUVEL TZ-3X X-RAY DIGITIZING SCANNER

    K Number: K890970 · Decision May 11, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    60
    Applicant Total
    1
    Review Days
    73

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    Basic Information

    Device Name
    TRUVEL TZ-3X X-RAY DIGITIZING SCANNER
    K Number
    K890970
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2030
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Truvel Corp.
    Date Received
    February 27, 1989
    Decision Date
    May 11, 1989
    Product Code
    LMA
    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
    LMA Digitizer, Image, Radiological

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