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510(k) Data Aggregation

    K Number
    K063221
    Device Name
    MEDWEB ADVANCED 3D WEB PACS
    Date Cleared
    2006-12-12

    (49 days)

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

    NEXSYS ELECTRONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Advanced 3D Web PACS™ is a PACS and teleradiology system used to receive DICOM and other medical images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. Advanced 3D Web PACS™ is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information, Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammodraphic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA
    Device Description
    Advanced 3D Web PACS™ is a PACS system, comprised of acquisition components (Medweb secure DICOM Proxy Web Server, ), a central system manager component (Medical Transcription Server), a diagnostic workstation component (Radiologist Dashboard©), and an archiving component (DICOM Archive). The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. After receiving the procedure information or after receiving image objects, the central system manager searches for and retrieves relevant prior procedure data from the archive component. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the item from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. After using the workstation to view the images, the user optionally dictates a report into the system, after which, a user can play back the dictation and transcribe it to text. Once Advanced 3D Web PACS™ central system manager registers a report, the report is available for access by the referring physician, or it can be exported into an information system. At some configured point in time, the image data and the report information is delivered to the archiving component for backup and long-term storage.
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