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510(k) Data Aggregation

    K Number
    K240839
    Device Name
    OpenRad Cloud
    Date Cleared
    2024-04-24

    (28 days)

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

    OpenRad Services UK Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OpenRad Cloud PACS and Viewer is intended for use in the medical image analysis and diagnosis workflows of hospitals, imaging centres, radiologists, reading practices and is granted access to a patient image and associated demographic and report information, including Peer Review or Teleradiology providers. OpenRad Cloud PACS Viewer displays, modifies, and manages diagnostic quality DICOM images, including 3D visualisation and reordering functionality. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretations. Mammographic images may only be viewed using cleared monitors intended for mammography display. The device is not intended for use with mobile displays. Review of images require an optimum display of images. Only use cleared monitors and printers for diagnosis review of images. Follow the maintenance and care instructions given in the manufacturer's documentation.
    Device Description
    The OpenRad Cloud is a software device for the display and evaluation of 2D/3D visualization of DICOM compliant medical image data, such as CT, MRI, Mammogram, and Ultrasound scans. OpenRad Cloud principles of operation and its mode of action: 1. Receive/Send DICOM Studies; 2. Pre-process and archive in the correct folder; 3. Display study in the correct worklists for intended users; 4. Open the study for visualization together with any existing previous studies of the patient; 5. Produce, communicate and archive reports. The system is a client-server based architecture. OpenRad Cloud viewer requires a medical grade monitor for diagnostic reading of images, favouring the use of full radiology workstations. The OpenRad Cloud Software provides several levels of functionality to the user: - Basic analysis tools they use on a daily basis such as 2D review, orthogonal multiplanar reconstructions (MPR), oblique MPR, curved MPR, Slab MPR AvgIP, MIP, MinIP, measurements, annotations, reporting, distribution etc. - Tools for in-depth analysis, such as segmentation, endoscopic view, color volume rendered slabs, grayscale volume rendered slabs, 3D volume review, path definition and boundary detection. - Specialist tools and workflow enhancements for specific clinical applications which provide targeted workflows, custom UI, measurement and visualisation, including Virtual Colonoscopy, Vessel Analysis, Calcium Scoring, PET/CT, CT Lung Analysis, CT Dental and DCE-MRI Breast and Prostate.
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