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

    Dendrite Imaging System

    K Number: K253303 · Decision Nov 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    60

    Basic Information

    Device Name
    Dendrite Imaging System
    K Number
    K253303
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dendrite Imaging, Inc.
    Date Received
    September 29, 2025
    Decision Date
    November 28, 2025
    Product Code
    QDG
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QDG Parathyroid Autofluorescence Imaging Device

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