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510(k) Data Aggregation

    K Number
    K253303

    Validate with FDA (Live)

    Device Name
    Dendrite Imaging System
    Manufacturer
    Dendrite Imaging, Inc.
    Date Cleared
    2025-11-28

    (60 days)

    Product Code
    QDG
    Regulation Number
    878.4550
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K190891
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Dendrite Imaging System is indicated for use in real-time capturing and viewing of autofluorescent images of nerves and can be used as an adjunctive method to assist in the location of nerves during surgery. Use of the device is intended to assist, not replace, experienced visual assessment. The system is not to be used to confirm the absence of nerve tissue and is only to be used to assist in locating visually identified nerves.

    Device Description

    The Dendrite Imaging System provides real-time near ultraviolet (NUV) fluorescence imaging of nerve tissue. The device is indicated for use during open surgical procedures as an adjunctive method to assist in the location of nerves due to the autofluorescence of this tissue. Use of the Dendrite Imaging System is intended to assist, not replace, experienced visual assessment per the standard of care. The device is not to be used to confirm the absence of nerve tissue and is only to be used to assist in locating visually identified nerves.

    The Dendrite Imaging System enables surgeons to observe fluorescent images of nerve tissue thanks to the natural autofluorescence of this tissue when exposed to NUV light. The system consists of a handheld camera head linked by a custom cable to the control display. The camera head contains a CMOS video camera and white and NUV light-emitting diodes (LEDs). The NUV LED is used to excite the nerve and a camera inside the camera head captures the fluorescent image for display on the touchscreen monitor. The white LED is used to illuminate the surgical field and in the generation of an "overlay" view of the nerve autofluorescence with the surrounding area. The control display is an off-the-shelf integrated computer/touchscreen display that receives the digital video signals from the camera head and displays them. Adjustments to the LEDs and camera can be made through the user interface on the control display. The surgeon may also save images or video during camera use for later export to a USB.

    AI/ML Overview

    N/A

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