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510(k) Data Aggregation

    K Number
    K141979
    Device Name
    ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V.
    Date Cleared
    2014-08-19

    (29 days)

    Product Code
    OWB, JAA
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Allura Xper series and the Allura Xper OR Table series (within the limits of the used OR table) are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolization and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper and Allura Xper OR Table series is compatible with a hybrid Operating Room. Allura Xper FD10 is compatible with specified magnetic navigation systems. Combined with a qualified, compatible OR table, the Allura Xper OR Table series can be used for imaging in the Hybrid OR within the applications domains Neuro, Vascular, Non Vascular and Cardiac. The OR table can also be used standalone for surgical use in the OR.
    Device Description
    The Allura Xper family consists of the Allura Xper FD series and the Allura Xper OR Table series and is identified as Allura Xper FD R8.2.1. The Allura Xper FD R8.2.1 is a modular angiographic X-ray system, based on a set of components that can be combined into different single and biplane configurations to provide specialized angiography. Combined with a qualified, compatible OR table, the Allura Xper FD R8.2.1 can also be used for imaging in the Hybrid OR. The Allura Xper FD R8.2.1 is optionally provided with ClarityIQ technology, which utilizes the advanced XRES4 noise reduction algorithms to reduce quantum noise in X-ray images.
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