BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    PreXion3D Explorer

    K Number: K190320 · Decision Apr 15, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    133
    Applicant Total
    9
    Review Days
    61

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    Basic Information

    Device Name
    PreXion3D Explorer
    K Number
    K190320
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prexion Corporation
    Date Received
    February 13, 2019
    Decision Date
    April 15, 2019
    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 Prexion Corporation

    K Number Device Name
    K232166 PreXion3D Expedition
    K222150 PreXion3D Expedition
    K221525 PreXion3D Explorer PRO
    K203784 PreXion3D Explorer PRO
    K193329 PreXion3D Explorer EX
    K181983 PreXion 3D Excelsior
    K173878 PreXion3D Excelsior
    K161881 PreXion3D Excelsior