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510(k) Data Aggregation

    K Number
    K993227
    Device Name
    PHILIPS INTURIS DICOM RECORDER
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
    Date Cleared
    1999-12-21

    (85 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 DICOM Recorder is intended for use in recording cardio-vascular images produced in the examination room (from the INTEGRIS systems, Easy Vision 4.3 onwards, or 3D workstation), on a CD-R.

    Device Description

    PHILIPS Inturis DICOM Recorder is software that can be loaded on a Personal Computer or workstation with a Windows NT (4.0) Operating System.

    AI/ML Overview

    The provided text is a 510(k) summary for the Philips Inturis DICOM Recorder. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria, detailed performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

    Therefore, I cannot provide the requested information from the given text. The document is primarily focused on regulatory submission and demonstrating substantial equivalence rather than reporting on technical performance studies with specific statistical metrics.

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