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

    OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM

    K Number: K024012 · Decision Mar 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    7
    Review Days
    106

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    Basic Information

    Device Name
    OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
    K Number
    K024012
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Oec Medical Systems
    Date Received
    December 4, 2002
    Decision Date
    March 20, 2003
    Product Code
    JAA
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

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    Other Clearances by Ge Oec Medical Systems

    K Number Device Name
    K073543 OEC 9900 ELITE
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    K052039 GE OEC ALTITUDE
    K022069 OEC FLUOROTRAK 9800 PLUS
    K021049 OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
    K003837 FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM