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

    9600 FLUOROSCOPIC IMAGING SYSTEM

    K Number: K926056 · Decision Jan 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    81
    Applicant Total
    8
    Review Days
    51

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    Basic Information

    Device Name
    9600 FLUOROSCOPIC IMAGING SYSTEM
    K Number
    K926056
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oec-Diasonics, Inc.
    Date Received
    December 1, 1992
    Decision Date
    January 21, 1993
    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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