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

    QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)

    K Number: K993763 · Decision Nov 26, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    198
    Applicant Total
    17
    Review Days
    18

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    Basic Information

    Device Name
    QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)
    K Number
    K993763
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1600
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medis Medical Imaging Systems BV
    Date Received
    November 8, 1999
    Decision Date
    November 26, 1999
    Product Code
    IZI
    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
    IZI System, X-Ray, Angiographic

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