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

    SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC

    K Number: K852331 · Decision Aug 1, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    198
    Applicant Total
    8
    Review Days
    427

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    Basic Information

    Device Name
    SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC
    K Number
    K852331
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1600
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Scholten Surgical Instruments, Inc.
    Date Received
    May 31, 1985
    Decision Date
    August 1, 1986
    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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