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

    TF-63SA

    K Number: K904044 · Decision Nov 29, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    15
    Applicant Total
    146
    Review Days
    86

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    Basic Information

    Device Name
    TF-63SA
    K Number
    K904044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1610
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Toshiba America Medical Systems, In.C
    Date Received
    September 4, 1990
    Decision Date
    November 29, 1990
    Product Code
    KPW
    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
    KPW Device, Beam Limiting, X-Ray, Diagnostic

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