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510(k) Data Aggregation

    K Number
    K251827
    Device Name
    Azurion R3.1
    Manufacturer
    Philips Medical Systems B.V.
    Date Cleared
    2025-10-24

    (133 days)

    Product Code
    OWB
    Regulation Number
    892.1650
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K200917
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis 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.

    Patient Population:
    All human patients of all ages. Patient weight is limited to the specification of the patient table.

    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

    This array of functions offers the physician the imaging information and tools needed to perform and document minimally invasive interventional procedures.

    The Azurion R3.1 is available in identical models and configurations as the predicate device Azurion R2.1. Configurations are composed of detector type, monoplane (single C-arm) or biplane (dual arm), floor or ceiling mounted geometry, standard or OR table type and available image processing.

    Identical to the predicate device, the FlexArm option is available for the 7M20 configuration in Azurion R3.1 to increase flexibility in stand movement.

    Additionally, identical to the predicate device, Azurion R3.1 can be used in a hybrid operating room when supplied with a compatible operating room table.

    AI/ML Overview

    N/A

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