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

    SYNC-RX SYSTEM, MODEL AS00010

    K Number: K100849 · Decision May 21, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    198
    Applicant Total
    1
    Review Days
    56

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    Basic Information

    Device Name
    SYNC-RX SYSTEM, MODEL AS00010
    K Number
    K100849
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1600
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sync-Rx, Ltd.
    Date Received
    March 26, 2010
    Decision Date
    May 21, 2010
    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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