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510(k) Data Aggregation

    K Number
    K110332
    Device Name
    CLEARCANVAS RIS / PACS
    Manufacturer
    CLEARCANVAS INC.
    Date Cleared
    2011-03-24

    (49 days)

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

    CLEARCANVAS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearCanvas RIS/PACS is an image management system whose intended use is to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM."For Presentation", and will include standard features and other tools for analyzing mammography images. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega-pixel resolution and meets other technical specifications approved by the FDA.
    Device Description
    ClearCanvas RIS/PACS is a Picture Archiving and Communication (PACS) software system for the management and review of medical image data, and other digital images. Such data can be received from all DICOMcompliant imaging modalities or imported directly into the system. This data can then be stored, archived, distributed, processed, enhanced, and displayed for review. Enhancement, processing and analysis of the image data includes but is not limited to compression, magnification, value-of-interest manipulation, orientation changes, image fusion and multiplanar reformat. Additional health data, such as patient demographics, from other information systems can be received from HL7-compliant sources. The ClearCanvas RIS/PACS is a system of interrelated software components: - . ClearCanvas Workstation – a desktop client that is primarily used to retrieve, display, enhance and analyze medical images. Access to patient demographic data is also possible through the Workstation when working with the RIS server. - . ClearCanvas Webstation – a browser-based web application that allows the user to retrieve images from the ImageServer for review. Primarily intended for referring physicians and as an image viewer for EMR systems, the images are JPEG-compressed. - . ClearCanvas ImageServer – a server application that receives images from imaging modalities, stores and archives them, and distributes them to client applications. - . ClearCanvas RIS – a server application that acts as an online transaction processor for the management of patient and workflow information. - . ClearCanvas IntegrationServer – a server application composed of optional modules that implement integration and interoperability, such as an inbound and outbound HL7 processor. - . ClearCanvas EnterpriseServer -- a server application that provides enterprise-wide facilities such as user authentication, authorization and auditing. Working in concert or stand-alone, each component plays a valuable role in the management information in the radiology reading room, the clinic, the referring physician's office, or any other patient care setting where access to medical imaging information is important. ClearCanvas RIS/PACS software is primarily written in C#, employing the most current best practices in objectoriented and component-oriented software architecture resulting in a highly scalable and extensible design. The system is also designed to work on generic PC hardware that meets the minimum system requirements.
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