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510(k) Data Aggregation

    K Number
    K994210
    Device Name
    INTURIS SUITE
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Date Cleared
    2000-02-04

    (52 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K972229
    Why did this record match?
    Device Name :

    INTURIS SUITE

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

    Philips Inturis Suite is intended to be used for the display and reading of cardiac angiographic images stored on a compact disk (CD) or an image server. Inturis Suite also allows the user to change the appearance of the images and export selected frames to other programs for printing and further manipulation.

    Device Description

    Philips Inturis Suite is software comprised of modular software programs designed to perform the necessary functions required for the import, storage, archive, review, analysis, reporting and database management of digital cardiovascular angiographic images in DICOM 3.0 formats within and beyond the Cath Lab domain. Inturis Suite allows multiple users to quickly access and transfer multiple angiographic exams. Inturis Suite software can be installed and run on Windows NT based personnel computers for small applications and on UNIX based servers for high performance applications. The modular software design of Inturis Suite, allows users to tailor their image archive, transfer and communication requirements based on their particular performance needs and the number of cath labs importing images to an Inturis Suite via DICOM. Inturis Suite software will be provided on a CD-Rom which contains the installation program, the applicable executable files, DLL files and a readme file.

    AI/ML Overview

    The provided document does not contain information about acceptance criteria or a study proving that the device meets such criteria.

    The document is a 510(k) summary for the Philips Inturis Suite, an image review software for angiographic X-ray systems. It primarily focuses on demonstrating substantial equivalence to a predicate device (ImageView Coronary Angiography Display and Review System by HeartWare, Inc.) by comparing technological characteristics and stating the intended use.

    Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. This information is typically found in performance studies, which are not present in this regulatory submission.

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