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510(k) Data Aggregation

    K Number
    K103182
    Device Name
    TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
    Manufacturer
    GENORAY CO., LTD.
    Date Cleared
    2011-01-14

    (78 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K070464
    Why did this record match?
    Device Name :

    TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

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

    Triana is intended for use as a software package which obtains medical images from CT, Cephalometric / Panoramic X-ray system & etc., stores those and provides 3D visualization, 2D analysis, various MPR(Multi-Planar Reconstruction) functions for further rapid and precise diagnosis.

    Device Description

    Triana is a computer based dental imaging software which obtains medical images taken from CT, Cephalometric / Panoramic X-ray system & etc. and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis.

    Triana is designed to provide users easy and familiar user-interface. Also Triana makes it possible to manage medical images more easily and provides advanced tools for 2D and 3D analysis with rendering functions.

    AI/ML Overview

    The provided text describes a 510(k) submission for a Picture Archiving and Communications System (PACS) called Triana. However, it does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details about sample sizes, expert qualifications, or ground truth establishment.

    The submission focuses on establishing substantial equivalence to a predicate device (CyberMed, Inc.'s OnDemand3D K070464). The text explicitly states:

    "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices."

    This statement implies that some form of evaluation was performed, but no details of such evaluation (e.g., acceptance criteria, detailed study results, methodologies) are provided in the given document excerpts.

    Therefore, I cannot populate the requested table and answer the questions based on the input.

    Key takeaway: The provided document is a 510(k) submission primarily focused on demonstrating substantial equivalence to a predicate device based on similar functions and characteristics, rather than a detailed report of a study with specific acceptance criteria and performance metrics.

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