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

    Smile Dx®

    K Number: K242437 · Decision May 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    36
    Applicant Total
    1
    Review Days
    271

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    Basic Information

    Device Name
    Smile Dx®
    K Number
    K242437
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2070
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cube Click, Inc.
    Date Received
    August 16, 2024
    Decision Date
    May 14, 2025
    Product Code
    MYN
    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
    MYN Analyzer, Medical Image

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