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510(k) Data Aggregation

    K Number
    K253714

    Validate with FDA (Live)

    Device Name
    IntraSight Plus
    Manufacturer
    Philips Image Guided Therapy Corporation
    Date Cleared
    2026-02-24

    (92 days)

    Product Code
    IYO,DSA,DSK,OWB
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    18 - 999
    Reference & Predicate Devices
    K190078,K190626
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    IntraSight Plus is a multi-function system intended to be used as an adjunct diagnostic tool for qualitative and quantitative evaluation of vascular morphology in coronary arteries and peripheral vasculature in patients eligible for endovascular procedures.

    The system, when configured with optional features, can also be used for:

    • quantitative evaluation of coronary physiology using pressure-derived ratios,
    • quantitative evaluation of coronary artery dimensions,
    • enhanced visualization of stent or balloon placement in coronary arteries, and
    • co-registration of an x-ray image with coronary intravascular ultrasound and/or coronary pressure-derived ratios

    in patients eligible for percutaneous coronary intervention.

    The IntraSight Plus IVUS function is indicated for use in patients undergoing conventional angiographic procedure to assess vascular morphology and to assess the need for additional treatment post percutaneous intervention. IVUS is obtained with a compatible ultrasound catheter and used as an adjunct to examine vascular morphology in the coronary arteries and vessels of the peripheral vasculature.

    The IntraSight Plus FFR and iFR functions are indicated for use in patients with signs of coronary artery disease undergoing coronary catheterization procedures to assess the hemodynamic significance of coronary lesions that may contribute to myocardial ischemia. FFR and iFR are obtained with a compatible pressure guide wire.

    Device Description

    Philips IntraSight Plus is a multi-modality, application-based platform providing a range of imaging, physiology and co-registration tools. It can be integrated with a compatible interventional X-ray system.

    Philips IntraSight Plus provides qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature in adult patients eligible for endovascular procedures. It is used to support conventional angiographic procedures, providing images of vessel lumen and wall structures.

    AI/ML Overview

    N/A

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