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

    SCEPTREP3 PET/CT

    K Number: K042428 · Decision Sep 17, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    100
    Review Days
    9

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    Basic Information

    Device Name
    SCEPTREP3 PET/CT
    K Number
    K042428
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hitachi Medical Systems America, Inc.
    Date Received
    September 8, 2004
    Decision Date
    September 17, 2004
    Product Code
    KPS
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KPS System, Tomography, Computed, Emission

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