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    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇷 Brazil

    EAGLE EDGE AXR90 and AXR120

    K Number: K210820 · Decision Aug 10, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    133
    Applicant Total
    2
    Review Days
    144

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    Basic Information

    Device Name
    EAGLE EDGE AXR90 and AXR120
    K Number
    K210820
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alliage S/A Industrias Medico Odontológica
    Date Received
    March 19, 2021
    Decision Date
    August 10, 2021
    Product Code
    OAS
    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
    OAS X-Ray, Tomography, Computed, Dental

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    Other Clearances by Alliage S/A Industrias Medico Odontológica

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