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

    CARDIOSPECT D90/CARDIO CAM

    K Number: K021823 · Decision Jun 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    2
    Review Days
    13

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    Basic Information

    Device Name
    CARDIOSPECT D90/CARDIO CAM
    K Number
    K021823
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nuclear Cardiology Systems, Inc.
    Date Received
    June 4, 2002
    Decision Date
    June 17, 2002
    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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    Other Clearances by Nuclear Cardiology Systems, Inc.

    K Number Device Name
    K013353 NEUROSPECTQUAD GAMMA CAMERA