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

    AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM

    K Number: K010721 · Decision Mar 30, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    198
    Applicant Total
    5
    Review Days
    18

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    Basic Information

    Device Name
    AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM
    K Number
    K010721
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1600
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medical Corp.
    Date Received
    March 12, 2001
    Decision Date
    March 30, 2001
    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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