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510(k) Data Aggregation

    K Number
    K983821
    Device Name
    PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
    Date Cleared
    1998-12-11

    (43 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K945460
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PHILIPS Inturis Cardio Image Viewing Package is intended for use in processing and viewing cardiac or cardiovascular images, resulting in quantitative and/or qualitative data that can be used to estimate cardiac or cardiovascular function.

    Device Description

    PHILIPS Inturis Cardio Image Viewing Package is software that can be loaded on a workstation which has a Windows NT (4.0) Operating System. The Inturis Cardio Image Viewing workstation provides for viewing and analysis of DICOM Cardiac images which are transported to the workstation via CD-Rom. Quantitative Coronary and Left Ventricular analysis may be performed on these images.

    AI/ML Overview

    The provided text is a 510(k) premarket notification for the Philips Inturis Cardio Image Viewing Package. This document outlines the intended use, system description, and substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study details, device performance metrics, sample sizes, ground truth establishment, or expert qualifications necessary to answer your request.

    Therefore, I cannot extract the requested information from the provided text. The document is primarily focused on demonstrating substantial equivalence for regulatory approval, not on presenting performance study results.

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