BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    SURGICAL MICROSCOPE SYSTEM ORBEYE with IR

    K Number: K190772 · Decision Oct 10, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    198
    Applicant Total
    102
    Review Days
    198

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    Basic Information

    Device Name
    SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
    K Number
    K190772
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1600
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Medical Systems Corp.
    Date Received
    March 26, 2019
    Decision Date
    October 10, 2019
    Product Code
    IZI
    Advisory Committee
    Radiology
    Review Advisory Committee
    NE
    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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