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510(k) Data Aggregation

    K Number
    K250955
    Manufacturer
    Date Cleared
    2025-10-22

    (205 days)

    Product Code
    Regulation Number
    870.1200
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The XC11 ICE Box Ultrasound System is intended for intra-cardiac and intra-luminal ultrasound imaging when operated with the XC11 ICE Catheter and XC11 ICE System Handle.

    The XC11 ICE Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

    The XC11 ICE Catheter is for use with Yorlabs XC11 ICE System Handle only.

    Device Description

    The XC11 ICE System, USA is a fully integrated imaging platform designed for wireless communications and a compact footprint. It provides precise, real-time visualization of intracardiac anatomy and devices positioned within the heart.

    The System is comprised of two main components:

    XC11 ICE Catheter (2D), USA
    A 9F, single-use, sterile device capable of real-time 2D side-view imaging for intracardiac and intraluminal ultrasound in adult and pediatric patients. The catheter features easy steering maneuverability via deflection and rotation, along with on-handle imaging controls for enhanced usability.

    XC11 ICE Box Ultrasound System, USA
    This unit houses the image data acquisition and computer modules for image display and includes a connector for interfacing with the XC11 ICE System Handle. The XC11 ICE Tablet with a touchscreen interface, enables technicians to control the system software efficiently.

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