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510(k) Data Aggregation

    K Number
    K081168
    Device Name
    BRIT PACS SYSTEMS
    Manufacturer
    BRIT SYSTEMS, INC.
    Date Cleared
    2009-03-23

    (333 days)

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

    BRIT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BRIT PACS Systems is an image management system whose intended use is to provide (scaleable) DICOM compatible PACS solutions for hospital and related institutions/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 Mammo tools. 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. Application areas include imaging centers, radiologist central reading rooms, and any other locations where trained medical professionals would require access or desire patient images, demographic information, or other patient medical information captured in the system.
    Device Description
    BRIT PACS Systems provides custom, turn-key solutions for PACS and teleradiology based systems on the latest DICOM standards. Using PACS, medical images can be made available at multiple locations - virtually anywhere at any time. Modular components make BRIT's solutions flexible, upgradeable, and scaleable. BRIT SCAN is a high-quality film digitization system that allows standard radiographs to be converted into electronic images for transmission to PACS and teleradiolgy systems. BRIT Scan allows the users to integrate standard radiographic studies, which are often used for comparison studies, into the PACS strategy. BRIT Quality Workbench is a DICOM based application that runs on a PC and is used to provide patient demographic and image data quality control functions within the PACS system. BRIT Roentgen RIS provides a hospital or clinic with automated tools to electronically schedule and manage patient exam information. The Roentgen RIS utilizes a web based client that provides referring physicians the added flexibility to instantly view and schedule their own patients' radiographic services. The Roentgen RIS also accesses the same database as BRIT'S PACS solution. BRIT Roentgen Files is the main product for exam and report storage in a PACS environment. It runs a DICOM Server and Web Server plus a selection of the following applications, all using the same database. - DICOM Archive - Modality Worklist Server - HL-7 Interface Engine - Order Entry/Scheduling package BRIT Viewing Workbenches offer different viewing applications to address the differing needs of the users. BRIT Vision is a diagnostic reading workbench which provides radiologists and high-power users a fully configured 12-bit DICOM image viewing workstation. BRIT Vision Mammography Module is an optional diagnostic module utilizing 5MP monitors that runs in the BRIT Vision medical image viewing workstation. BRIT View is a clinical viewing workstation or diagnostic reading workbench which provides high quality image viewing and manipulation capabilities in a fully configured 12-bit DICOM workstation, for use in radiology or non-radiological area of the facility such as ER, Surgery, ICU, and other areas. BRIT Lite is a viewing application that responds to the needs of healthcare organization that require access to images anywhere, anytime, but without the need for advanced visualization tools or large application on each workstation. BRIT Roentgen Burner is a DICOM compliant automated solution for producing custom-labeled CD's and or DVD's that contain medical images plus BRIT's image viewing software. Radiological studies are sent to this device from any BRIT DICOM workstation on the network. BRIT Roentgen Works is a workflow management service for radiologists to provide remote reading services for multiple health care facilities.
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