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510(k) Data Aggregation

    K Number
    K050033
    Device Name
    LUCION
    Manufacturer
    MEVISYS CO. LTD
    Date Cleared
    2005-02-11

    (35 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K022692,K020929
    Why did this record match?
    Device Name :

    LUCION

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

    The Lucion™ is a software application for the display and 3D visualization of medical image data derived from various sources (i.e. CT scanners, MRI scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations.

    Device Description

    Mevisys Lucion™ is a PC-based software application that imports medical images (i.e. CT, MRI modalities) in a DICOM format and provides various functions for rapid and easy review. It includes 3D volume rendering, various MPR, and many 2D analysis tools. The tools manage images, requests, patients, examination etc. over a high-speed network to allow information and images flow throughout a user facility.

    AI/ML Overview

    I am unable to find any information about acceptance criteria or a study proving that the device meets acceptance criteria in the provided document. The document primarily describes the device (Lucion™ Picture Archiving Communications System), its predicate devices, and its FDA 510(k) clearance for marketing.

    The document does not contain:

    1. A table of acceptance criteria or reported device performance.
    2. Information on sample sizes, data provenance, or ground truth establishment for any test or training sets.
    3. Details about expert involvement, adjudication methods, or MRMC comparative effectiveness studies.
    4. Confirmation of a standalone performance study.

    The description of "Lucion™" indicates it is a PC-based software application that imports and processes medical images (CT, MRI) in DICOM format for display and 3D visualization. It also mentions that "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed," suggesting it's an aid for human interpretation rather than an autonomous diagnostic device with specific performance metrics.

    Therefore,Based on the provided document, the requested information regarding acceptance criteria and performance studies is not available.

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