Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K231385
    Device Name
    Rology Teleradiology Platform (v.1.22.1103)
    Manufacturer
    Date Cleared
    2023-09-20

    (131 days)

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

    Rology Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Rology Teleradiology Platform is a Web-based software system used to receive, view and manipulate DICOM images, schedule, provide textual reports, organize, store, and make such information available. When images are reviewed and used as an element of diagnosis, it is the responsibility of the qualified clinician to determine if the image quality is suitable for their clinical application. The Rology Teleradiology Platform is intended to be used by clinicians qualified in the use of radiological images for interpretation/diagnosis. Contraindications: Rology Teleradiology Platform is not intended for the acquisition of mammographic image data for primary diagnosis.
    Device Description
    Rology Teleradiology Platform developed by Rology Inc. is a Software as a Medical Device (SaMD) system used to receive DICOM images, schedule information, and textual reports, organize and store them in an internal format, and make that information available across a network via web and customized user interfaces. The Rology Teleradiology Platform is intended to be used by trained and qualified healthcare professionals, including radiologists, technologists, and medical professionals, in hospitals, clinics, and medical imaging centers, to aid the radiologists in reading, interpreting, and reporting. When images are reviewed and used as an element of diagnosis, it is the responsibility of the trained radiologist to determine if the image quality is suitable for their clinical application, so the radiologist retains the ultimate responsibility for making the final diagnosis decision. Contraindications: Rology Teleradiology Platform is not intended for the acquisition of mammographic image data for primary diagnosis. Rology Teleradiology Platform is designed to integrate with current medical systems through standard medical protocols: - . DICOM: for exchanging medical imaging. - HL7/FHIR: for exchanging electronic health records . The Rology Teleradiology Platform is to be used to view DICOM-compliant studies, which are stored in the cloud using to AWS's S3 service and is intended for professional use only as a viewing tool for medical image studies. The Rology Teleradiology Platform is comprised of the following modules/functions: - Acquiring studies by the Rology Connect module which allows for the automatic . acquisition of images from DICOM-compliant devices. It receives, anonymizes, compresses, and uploads the studies to the platform using AWS's S3 service. A third-party DICOM device sends the images to the Rology DICOM node, which will extract DICOM data and upload the images to cloud servers. - Scheduling and organizing studies after being uploaded by the Workflow Manager. . - View DICOM-compliant studies using the DICOM Viewer software which will fetch . images and data from backend servers, to allow users to view those images on their personal computers, to diagnose, manipulate, and interpret the studies. - Report textual/transmission to the healthcare facility using the Reporting Tool which is part of the DICOM Viewer, to Incorporate non-image data, such as scanned documents, using consumer industry standard formats like PDF (Portable Document Format). The report will be sent securely to the healthcare facility for review/acceptance. The features and functions of Rology DICOM Viewer module, which includes Viewer technology and features include: General Functions: - . Receive DICOM images from the acquisition device - . Textual reports, and transmit the reports securely to the hospital - Store images in a secure cloud environment . Basic Imaging functions: - Grayscale Image Rendering ● - Localizer Lines ● - Localizer Point . - Distance Markers ● - Study Data Overlays ● - Stack Navigation Tool ● - Window/Level Tool - Zoom Tool ● - . Panning Tool - Clockwise/Counterclockwise Rotation . - Color Inversion ● - Area Measurement Annotation ● - Angle Measurement Annotation ● - . Added keyboard shortcuts for some tools - Orientation Markers Advanced imaging functions - Multi-Planar Reconstruction (MPR) • - . Maximum Intensity Projection (MIP) The Rology DICOM Viewer module is the only 'module' of the system that is believed to meet the definition of being a regulated medical device. The other modules of the Rology Teleradiology Platform are included to provide a complete understanding of the software system and its interactions with the intended user(s).
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1