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510(k) Data Aggregation

    K Number
    K233226
    Device Name
    FlexView Diagnostic (v1.1.20)
    Date Cleared
    2024-01-17

    (111 days)

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

    Radical Imaging, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    FlexView Diagnostic is a software application used for reference and diagnostic viewing and analysis of multi-modality medical imaging and non-imaging data (e.g., video information) with associated reports and information. FlexView Diagnostic enables qualified healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data. FlexView Diagnostic allows qualified users to perform simple and complex image manipulations (including window/level, markups, 3D visualization) and measurements. Not intended for primary diagnosis of mammographic images. Not intended for diagnostic use on mobile devices.
    Device Description
    FlexView Diagnostic is a stand-alone Web-based DICOM medical image viewer which allows downloading, reviewing, manipulating, and visualizing medical multi-modality image data in DICOM format and other data. FlexView Diagnostic is a server-based solution that may integrate with healthcare facility software systems and display DICOM images. FlexView Diagnostic enables healthcare professionals to access, manipulate, and measure DICOM images and collaborate using diagnostic quality medical images without installing client software. The FlexView Diagnostic application has the following primary features and functions: - Zero-footprint Web browser based - Medical image upload, transfer and display of medical images between facilities - Allows access to images for all participants in the healthcare process, including radiologists, technologists, physicians, nurses and other patient care practitioners - Serves as an information and data management system for DICOM and non-DICOM medical images - Contains functionality to view, annotate and measure images - Contains industry-standard tools for image manipulation, annotation and measurements - Advanced image manipulation functions like view synchronization across series, 3D visualization like MIP and MPR - Encrypted transmission of medical images through secured networks - HIPAA-compliant data management, including centralized storage of user activities via audit trails FlexView Diagnostic consists of configurable software-only modules that display and process 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 with which users interact when viewing the imaging data and other 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. FlexView Diagnostic can connect and access the medical images across different sources in a health system: such as an existing PACS, cloud storage or local server-based storage. The data connection and imaging data processing is handled by the FlexView backend module which supports the standardized transmission protocol as defined in the DICOM standard. Users interact with FlexView Diagnostic through a standard web browser, thus providing access to full quality images from anywhere with an Internet access. Flex View Diagnostic utilizes authorization and authentication mechanisms to ensure that only authorized users can access the imaging data. The system extends beyond the hospital and its internal network. With proper authorization, FlexView Diagnostic 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 opinions.
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