BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    SOPIX

    K Number: K142995 · Decision Aug 17, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    205
    Applicant Total
    4
    Review Days
    305

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    Basic Information

    Device Name
    SOPIX
    K Number
    K142995
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sopro - Acteon Group
    Date Received
    October 16, 2014
    Decision Date
    August 17, 2015
    Product Code
    MUH
    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
    MUH System, X-Ray, Extraoral Source, Digital

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    Other Clearances by Sopro - Acteon Group

    K Number Device Name
    K153367 S698 Symbioz flow
    K151053 PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner
    K140013 SOPIX INSIDE, SOPIX2 INSIDE