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

    LSO PET/CT HIREZ 64

    K Number: K042467 · Decision Oct 1, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    19
    Review Days
    18

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    Basic Information

    Device Name
    LSO PET/CT HIREZ 64
    K Number
    K042467
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cti Pet Systems, Inc.
    Date Received
    September 13, 2004
    Decision Date
    October 1, 2004
    Product Code
    KPS
    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
    KPS System, Tomography, Computed, Emission

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    Other Clearances by Cti Pet Systems, Inc.

    K Number Device Name
    K050509 LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I
    K040933 ECAT HRRT
    K033431 LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ
    K023768 ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16
    K023518 ECAT LSO PET/CT 16
    K021633 ECAT VISION PET SCANNER, MODELS 3000 & 5000
    K013504 MODIFICATION TO: ECAT LSO PET/CT SCANNER
    K003241 ECAT PET SCANNER
    K002584 ECAT ACCEL PET SCANNER
    K002715 ECAT PET SCANNER
    Search all 19 clearances from Cti Pet Systems, Inc. →