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

    LIXISCOPE - OR LIXI

    K Number: K820658 · Decision May 18, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    81
    Applicant Total
    2
    Review Days
    69

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    Basic Information

    Device Name
    LIXISCOPE - OR LIXI
    K Number
    K820658
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Lixi, Inc.
    Date Received
    March 10, 1982
    Decision Date
    May 18, 1982
    Product Code
    OXO
    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
    OXO Image-Intensified Fluoroscopic X-Ray System, Mobile

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    Other Clearances by Lixi, Inc.

    K Number Device Name
    K925251 LIXI IMAGING SCOPE. MODIFICATION