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510(k) Data Aggregation

    K Number
    K041935
    Device Name
    DR SYSTEMS PACS, RELEASE 6.1
    Manufacturer
    DR. SYSTEMS, INC.
    Date Cleared
    2004-08-16

    (28 days)

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

    DR. SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DR Systems PACS, Release 6.1 is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. The DR Systems PACS interfaces to various storage and printing devices using DICOM or similar interface standards. The DR Systems PACS displays, stores, prints, and telecommunicates images from a number of medical modalities, including but not limited to MRI, CT, US, PET, DXA (bone densitometry), imaging, computed radiography, digital radiography, digitized films, digital photographs, mammographic images, and processed data from FDAcleared third party image processing systems, including FDA-cleared systems for computer-aided detection and advanced image processing (e.g. 3-D processed images such as those produced by Voxar Corp.). Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.
    Device Description
    The DR Systems Dominator Reading Station is a multi-modality PC-driven review workstation. It includes a color flat panel monitor and two or more high-resolution monitors, which may be high resolution CRT's or flat panel monitors. A standard keyboard is provided as well as a standard mouse. Optionally, a microphone may be attached. DR Systems also provides components as described in the DR Systems User Guide, including: - Ambassador Viewing Station Software typically used by referring doctors for viewing images, playing audio, or viewing reports, but not used for primary reading. - Communicator Web Distribution Server. - Guardian Archive System and optional DVD jukebox or EMC Centera archive. - Catapult Technologist Workstation—for image and data input and editing as required. - Universal Manager Workstations-primarily used by clerks for medical records and report management. The DR Systems PACS, Release 6.1, provides the following features to the radiologist: - DR Systems viewing software provides simple tools to enable display of any digital image at the same resolution as the initial acquired digital image, independent of the monitor matrix size. - DR Systems provides several DICOM-compliant methods of lossless and lossy image compression (JPEG2000 and JPEG). - The DR Systems PACS outputs DICOM medical image data to printers that adhere to appropriate regulatory standards. - DR Systems archives medical imaging data in DICOM format on appropriate media (DVD, RAID servers, EMC Centera or other computer storage systems) that are designed to prevent data loss. - DR Systems provides a software warning that identifies any image series where any image was not viewed prior to marking an examination as read, in order to prevent the reading physician from completing interpretation of an exam while inadvertently failing to view all images. - DR Systems enables storage and reading of digitized images, including film-screen mammograms.
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