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510(k) Data Aggregation

    K Number
    K022692
    Device Name
    VOXELPLUS PACS
    Manufacturer
    MEVISYS CO. LTD
    Date Cleared
    2002-10-11

    (59 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K992654
    Why did this record match?
    Device Name :

    VOXELPLUS PACS

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

    The VoxelPlus™ is a software application for the 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.

    Typical users of this system are trained professionals, including physicians, nurses, and technicians.

    Device Description

    Mevisys VoxelPlus™ 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

    The provided text does not contain information about acceptance criteria or specific studies proving the device meets acceptance criteria. The document is a 510(k) summary for the "VoxelPlus™" Picture Archiving Communications System, which primarily focuses on establishing substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information.

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