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

    Diagnocat

    K Number: K252934 · Decision Jan 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    36
    Applicant Total
    2
    Review Days
    122

    Basic Information

    Device Name
    Diagnocat
    K Number
    K252934
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2070
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DGNCT, LLC
    Date Received
    September 15, 2025
    Decision Date
    January 15, 2026
    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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