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

    SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX

    K Number: K875370 · Decision May 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    23
    Review Days
    139

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    Basic Information

    Device Name
    SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX
    K Number
    K875370
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Shimadzu Precision Instruments, Inc.
    Date Received
    December 31, 1987
    Decision Date
    May 18, 1988
    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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