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510(k) Data Aggregation

    K Number
    K984545
    Device Name
    RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
    Date Cleared
    1999-02-25

    (65 days)

    Product Code
    IZI
    Regulation Number
    892.1600
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS

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

    The Philips Integris Series Release 2 systems are intended for use in acquiring diagnostic quality images during cardiac, angiographic, vascular, neurovascular, and interventional applications.

    Device Description

    The Philips Integris Series Release 2 systems include the Integris H5000, BH5000, V5000, BV5000, and HM2000. These systems are fully integrated, single and biplane, cath labs.

    AI/ML Overview

    The provided text describes a 510(k) summary for the Philips Integris Series Release 2 systems, an angiographic X-ray system. This document outlines the intended use and system description, but does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot populate the requested table or sections. The document focuses on regulatory approval and safety/software information, not clinical performance studies against specific acceptance criteria.

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