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510(k) Data Aggregation
K Number
K223425Device Name
MD.ai Viewer
Manufacturer
Date Cleared
2023-02-10
(88 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MDAI Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MD.ai Viewer is a software-based viewer intended to be used with off-the-shelf hardware for the display of DICOM and non-DICOM medical images and other healthcare data to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, display, and measurement of image data.
MD.ai Viewer allows users to perform image manipulations, including window/level, rotation, measurement and markup. MD.ai Viewer provides 2D display, Multi-Planar Reformatting and 3D visualization of medical image data.
Mobile usage is for reference and referral only.
MD.ai Viewer is not intended for primary mammography interpretation.
Device Description
MD.ai Viewer is a software-based medical image viewer used with off-the-shelf workstation and web browsers for the 2D & 3D visualization of DICOM and non-DICOM medical images. MD.ai Viewer is intended for storage, display, manipulation, measurement 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, annotation and measurement.
- . Metadata information and orientation labels display
- . Advanced image manipulation functions like view synchronization across series, 3D visualization like MIP and MPR
- . Advanced image processing filters like histogram equalization (CLAHE) filter to aid in visualization of pathological features in the images
- . Encrypted transmission of medical images through secured networks
- . Encrypted storage of medical images
- . HIPAA-compliant data management, including centralized storage of user activities via audit trails.
- . Management of users, roles, and permissions
MD.ai Viewer 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 which users interact with in viewing the imaging 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.
MD.ai Viewer 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 MD.ai Viewer which can be shared and enables collaboration with other users. The data connection and imaging data processing is handled by MD.ai Viewer backend module which supports the standardized transmission protocol as defined in the DICOM standard. In situation where secure network link is not available between health system and MD.ai cloud instance, the MD.ai Viewer proxy server can provide a secure and encrypted transfer of imaging data.
Users interact with MD.ai Viewer through a standard web browser, thus providing access to full quality images from anywhere and supporting a greater efficiency for care. MD.ai Viewer 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 proper authorization, MD.ai Viewer 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.
MD.ai Viewer provides end-users with the ability for industry standard features such as Window/ Level, Image Flip and Rotate, Invert, Hanging Protocol, Image Measurements, and Keyboard/Mouse shortcuts. Images are initially displayed in the 2D view mode, but with the ability to toggle into advanced viewing mode of 3D/MPR for relevant exam type. It supports processing and displaying Multiplanar Reconstruction (MPR) and different intensity rendering modes based on user-defined slab thickness. It also provides image processing filters like histogram equalization (CLAHE) filter to better visualize pathological features when displaying low contrast images from some modality devices.
MD.ai Viewer provides an image rendering mechanism that preloads lower resolution images during image scrolling to improve interactivity and performance for users operating 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. MD.ai Viewer tracks user activity via audit trails and stores the audit data on the centralized server
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