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510(k) Data Aggregation

    K Number
    K243645
    Date Cleared
    2025-09-22

    (300 days)

    Product Code
    Regulation Number
    892.1600
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    IC-Flow™ Imaging System 2.0, used in conjunction with Indocyanine Green (ICG), is indicated for fluorescence imaging of blood flow, tissue perfusion, and the lymphatic system in both adult and pediatric patients one month of age and older. Upon intravenous administration of ICG, the IC-Flow™ Imaging System 2.0 is used for fluorescence angiography before and after vascular, and plastic, micro-, and reconstructive procedures.

    Additionally, upon subcutaneous administration, the system is used for fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels.

    Device Description

    The IC-Flow™ Imaging System 2.0 is a real time near-infrared (NIR) fluorescence imaging system which facilitates visualization of the distribution and intensity of the Indocyanine Green (ICG) fluorescent imaging agent during medical procedures.

    The IC-Flow™ Imaging System 2.0 consists of a Controller with further connections to LAN and HDMI and a handheld Camera. The IC-Flow™ Imaging System 2.0 has a medical, near-infrared (NIR) Camera which emits a light to excite the ICG molecules and view ICG emitted fluorescence. The captured fluorescent image data is displayed on the Controller and/or connected monitor.

    Images and videos are recorded using buttons located on the Camera and icons on the Controller. The NIR light source illumination (excitation light) and Camera sensitivity can also be adjusted using controls on either the Camera or Controller. Images are stored in the Controller but can easily be transferred to a USB memory device, Cloud Drive or an external mass storage device.

    When ICG is injected consistent with its indications for use, it binds to plasma proteins and exhibits fluorescence when illuminated with near infrared (NIR) light. The excitation light source of IC-Flow™ imaging System 2.0 consists of a high-power LED.

    AI/ML Overview

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