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510(k) Data Aggregation

    K Number
    K070606
    Device Name
    VISIO+CD VIEWER# KPSCDVE01
    Manufacturer
    KEOSYS S.A.S.
    Date Cleared
    2007-04-24

    (50 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K062163
    Why did this record match?
    Device Name :

    VISIO+CD VIEWER# KPSCDVE01

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

    Visio+ CD Viewer is a software component that is used for viewing medical images stored on a CD-ROM. This software is not meant for primary image interpretation in mammography.

    Visio+ CD Viewer is located on the CD-ROM with the medical images. Visio+ CD Viewer provides tools for image review and manipulation which can only be used with the medical images present on the CD-ROM.

    Typical users of Visio+ CD Viewer are trained professionals, including physicians and radiologists.

    Device Description

    Visio+ CD Viewer is a component software which must be burned on a CD-ROM with medical images by another Medical Device.

    Visio+ CD Viewer operates only on a computer that meets the following requirements: Windows 2000/XP, Pentium III 1 GHz or better, 512 Mo RAM, minimum display resolution 1024x768, a CD or DVD drive. Visio+ CD Viewer provides tools for image review and manipulation.

    AI/ML Overview

    This submission describes the Visio+ CD Viewer, a software component designed for viewing medical images stored on a CD-ROM. The document mentions "Testing: Visio+ CD Viewer is tested according to the specifications that are documented in a Software Test Plan. Performance and functional testing are an integral part of Keosys's software development process." However, it does not provide details of specific acceptance criteria, studies, or performance results. Therefore, I cannot generate the requested table or answer most of the questions as the information is not present in the provided text.

    Based on the provided text, the following information can be extracted:

    7. The type of ground truth used:
    Not specified, but functional and performance testing are mentioned.

    8. The sample size for the training set:
    Not specified, as this device is a viewer and not an AI/ML algorithm requiring a training set in the conventional sense.

    9. How the ground truth for the training set was established:
    Not applicable, as this device is a viewer and not an AI/ML algorithm requiring a training set in the conventional sense.

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