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    K Number
    K254186

    Validate with FDA (Live)

    Device Name
    Azurion R3.1
    Manufacturer
    Philips Medical Systems B.V.
    Date Cleared
    2026-01-16

    (24 days)

    Product Code
    OWB
    Regulation Number
    892.1650
    Type
    Special
    Panel
    Radiology
    Age Range
    All
    Reference & Predicate Devices
    K251827
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K251827

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Azurion series (within the limits of the used Operating Room table) are intended for use to perform:

    • Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedures.
    • Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.

    Additionally:

    • The Azurion series can be used in a hybrid Operating Room.
    • The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.
    Device Description

    The Azurion R3.1 is classified as an interventional fluoroscopic X-Ray system. The primary performance characteristics of the Azurion R3.1 include:

    • Real-time image visualization of patient anatomy during procedures
    • Imaging techniques and tools to assist interventional procedures
    • Post processing functions after interventional procedures
    • Storage of reference/control images for patient records
    • Compatibility with hospital information systems (HIS) and image archiving systems via DICOM
    • Built in radiation safety controls.

    The only changes to the subject device, Azurion R3.1 includes the design change to the mattress accessory for all the existing mattresses of the predicate device (Azurion R3.1, K251827, 24 October 2025) and introduction of new gray color mattress. The change includes the addition of a hook and loop fastener (Velcro) solution for use between the mattress and the system integrated patient table (AD7X), to ensure that the mattress does not slip from the patient table.

    AI/ML Overview

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