BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Portable X-ray System (Model: MINIX-V / MINIX-S)

    K Number: K152859 · Decision Dec 3, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    189
    Applicant Total
    1
    Review Days
    64

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    Basic Information

    Device Name
    Portable X-ray System (Model: MINIX-V / MINIX-S)
    K Number
    K152859
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012)
    Date Received
    September 30, 2015
    Decision Date
    December 3, 2015
    Product Code
    EHD
    Advisory Committee
    Dental
    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
    EHD Unit, X-Ray, Extraoral With Timer

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