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

    TCT-500S COMPUTED TOMOGRAPHY X-RAY SYSTEM

    K Number: K896456 · Decision Mar 8, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    146
    Review Days
    115

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    Basic Information

    Device Name
    TCT-500S COMPUTED TOMOGRAPHY X-RAY SYSTEM
    K Number
    K896456
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Toshiba America Medical Systems, In.C
    Date Received
    November 13, 1989
    Decision Date
    March 8, 1990
    Product Code
    JAK
    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
    JAK System, X-Ray, Tomography, Computed

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