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510(k) Data Aggregation

    K Number
    K233331
    Device Name
    MediOMx
    Manufacturer
    Date Cleared
    2024-06-17

    (262 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    PMX Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MediOMx is a software-based viewer intended to be used with off-the-shelf hardware for the display of DICOM data to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, and display of image data. MediOMx allows users to perform image manipulations, including window/level, pan, zoom, and rotation. MediOMx provides 2D display, Multi-planar Reformatting of medical image data. MediOMx is not intended for primary mammography interpretation. Mobile usage is for reference and referral only.
    Device Description
    MediOMx is a software-based medical image viewer used with web browsers for the 2D visualization of DICOM and non-DICOM medical images. MediOMx is intended for storage, display, manipulation, and processing of radiological data, including images, reports and other clinical information. It has the following primary features and functions: - Zero-footprint HTML5 medical image upload, transfer and display of medical images between facilities - Easy access to images for all participants in the healthcare process, including radiologists, technologists, physicians, nurses and other patient care practitioners - Serve as information and data management system for for DICOM and non-DICOM medical images - Tools for image manipulation (e.g.pan, zoom, rotate, window level) - Metadata information and orientation labels display - Advanced image manipulation functions like view synchronization across series, 3D visualization like MIP and MPR - Encrypted transmission of medical images through secured networks - Encrypted storage of medical images - HIPAA-compliant data management, including centralized storage of user activity via audit trails. - Management of users, roles, and permissions - It supports optional integration with FDA-cleared 3rd party AI models. It sends the input study to the 3rd party AI model, receives the AI output and displays outputs of the 3rd party AI model "as-is" in MediOMx for visualization by the Radiologist to assist in diagnosing the study. Outputs are displayed in accordance with the 3rd party provider's regulatory clearance. The original image is always accessible MediOMx consists of a cloud-based application that displays and processes digital medical images, and associated medical information to aid in the day-to-day operations and workflow of clinicians and healthcare practitioners. The web browser based medical image viewer serves as the frontend module which users interact with in viewing data. The backend module handles the connection and processing of data from a variety of sources within the health system, in view of preparing visualizations to be rendered by the viewer. MediOMx can connect and access the medical images across different sources in a health system: an existing PACS or VNA, cloud storage or local server-based storage. Users can also upload images securely into MediOMx which can be shared and enables collaboration with other users. The data connection and imaging data processing is handled by the MediOMx backend module which supports the standardized transmission protocol as defined in the DICOM standard. Users interact with MediOMx through a standard web browser, thus providing access to full quality images from anywhere and supporting a greater efficiency for care. MediOMx utilizes authorization and authentication mechanisms that enforces authorized users to access the imaging data. The system extends beyond the hospital and its internal network. With a proper network, MediOMx can be accessed by clinical users outside of the hospital network. This way referring physicians can easily call up the imaging data of their patients or external expert accessing the imaging data for additional opinion. MediOMx provides end-users with the ability for industry standard features such as Window/ Level, Image Flip and Rotate. Images are initially displayed in the 2D view mode, but with the ability to toggle into advanced viewing mode of MPR for relevant exam types. It supports processing and displaying Multiplanar Reconstruction (MPR). MediOMx provides an image rendering mechanism that preloads lower resolution images during image scrolling to improve interactivity and performance for users operang in lower network bandwidth while the full quality image is loaded in the background. The use of a secure data transmission protocol and data encryption ensure high data security for data management via the internet. MediOMx tracks user activity via audit trails and stores the audit data on the centralized server.
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