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

    ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray

    K Number: K152489 · Decision Feb 4, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    133
    Applicant Total
    7
    Review Days
    156

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    Basic Information

    Device Name
    ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray
    K Number
    K152489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Panoramic Corp.
    Date Received
    September 1, 2015
    Decision Date
    February 4, 2016
    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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