BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Digital Intraoral X-ray Imaging System

    K Number: K212279 · Decision Oct 7, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    205
    Applicant Total
    21
    Review Days
    79

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    Basic Information

    Device Name
    Digital Intraoral X-ray Imaging System
    K Number
    K212279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Iray Technology Taicang , Ltd.
    Date Received
    July 20, 2021
    Decision Date
    October 7, 2021
    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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