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

    CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE

    K Number: K112474 · Decision Sep 23, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE
    K Number
    K112474
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cedars-Sinai Medical Center
    Date Received
    August 26, 2011
    Decision Date
    September 23, 2011
    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 Cedars-Sinai Medical Center

    K Number Device Name
    K172609 CSMC Cardiac Suite
    K141652 CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE
    K123433 CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE
    K100714 CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01