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

    OEC 3D

    K Number: K203346 · Decision Mar 5, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    81
    Applicant Total
    11
    Review Days
    112

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    Basic Information

    Device Name
    OEC 3D
    K Number
    K203346
    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, Inc.
    Date Received
    November 13, 2020
    Decision Date
    March 5, 2021
    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 Ge Oec Medical Systems, Inc.

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    K043076 GE OEC FLUOROSTAR
    K041931 OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION
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