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510(k) Data Aggregation

    K Number
    K252891

    Validate with FDA (Live)

    Device Name
    MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
    Manufacturer
    Bayer Medical Care, Inc.
    Date Cleared
    2026-02-13

    (155 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    K241849,K182276
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MEDRAD® MRXperion MR Injection System is a syringe‐based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners. Only trained healthcare professionals are intended to operate this device. For a complete list of compatible contrast agents for use with the MEDRAD MRXperion MR Injection System, refer to the MRXperion MR Injection System Operation Manual. The ISI2 Module is indicated for the specific purpose of allowing an injector to interface with an imaging scanner.

    Device Description

    The MRXperion Injection System is a software-controlled, electromechanical medical device used for the administration of intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) procedures. Commonly referred to as an automated injection system, it is designed to allow a user to fill disposable syringes and then to perform an injection with a user-programmed volume and flow rate.

    The MRXperion Injection System is comprised of a Scan Room Unit (SRU), Control Room Unit (CRU) and Single Use, Disposable Syringe Kit.

    The SRU is located within the scan room whereas the control room unit is not. The SRU, via a wired connection, interfaces with the control room unit. The CRU, also known as the workstation, includes a graphical user interface for the injector. The operator can use the touchscreen display to manage protocols and initiate and execute injections. However, the SRU can be used to also initiate and execute injections.

    The fluids are delivered from a single use only, sterile disposable set that includes one 65 mL syringe for contrast media and one 115 mL syringe for saline.

    The injection system is intended to be used in an MR suite. The MR suite may be located in a mobile medical imaging trailer. The injection system is intended to be operated by personnel with training and experience in MR procedures and use of MR injection systems. Operators will consist of radiological technologists trained in the use of the equipment. This system is intended for use with the general patient population, including adults and pediatrics.

    The MRXperion Injection System subject to this submission includes modified hardware and software as compared to the most recent clearance (K182276). The submission also includes an additional connectivity accessory, Imaging System Interface (ISI2) Module. The design changes do not involve any changes to the MRXperion MR Injection System Syringe Kit.

    AI/ML Overview

    N/A

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