LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252645
    Device Name
    LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub
    Manufacturer
    Philips Medical Systems Nederland B.V.
    Date Cleared
    2025-10-24

    (64 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Type
    Abbreviated
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K233853
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LumiGuide Equipment is a visualization device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected LumiGuide Wire and, optionally, a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real-time of the connected LumiGuide Wire and, of an endovascular catheter, when combined with a LumiGuide 3D Hub.

    The LumiGuide Wire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.

    The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with a LumiGuide Wire and the LumiGuide Equipment.

    Device Description

    The LumiGuide system consists of the following primary devices:

    The LumiGuide Equipment R2.1 is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a real time 3D image of a LumiGuide Wire and, optionally, an endovascular catheter when combined with LumiGuide 3D Hub, and overlay this on real time or pre-recorded X-ray images and/or on a pre-operative CT volume. The LumiGuide Equipment R2.1 comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component.

    The LumiGuide Wire is a sterile, single use, angiographic guidewire with Fiber Optic RealShape (FORS) technology that is available in two configurations: LumiGuide Navigation Wire 3D Ultra and LumiGuide Navigation Wire 3D Plus. The primary function of the LumiGuide Wire is to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature. The LumiGuide Wire can be visualized in 3D in real time by the LumiGuide Equipment R2.1 using FORS technology.

    The LumiGuide 3D Hub is a sterile, single use accessory to the LumiGuide Equipment R2.1 that connects to the luer connector of endovascular catheters. When the LumiGuide Hub is connected to an endovascular catheter and is used in combination with a LumiGuide Wire, the LumiGuide Equipment R2.1 enables real time 3D visualization of the connected endovascular catheter.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1