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

    I-MAX TOUCH 3D

    K Number: K130443 · Decision Jun 14, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    133
    Applicant Total
    6
    Review Days
    113

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    Basic Information

    Device Name
    I-MAX TOUCH 3D
    K Number
    K130443
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Owandy
    Date Received
    February 21, 2013
    Decision Date
    June 14, 2013
    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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