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510(k) Data Aggregation

    K Number
    K042700
    Device Name
    IMAGE MEDICAL ACQUISITION STATION (IMAS)
    Date Cleared
    2004-11-08

    (39 days)

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

    ERAD IMAGEMEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Image Medical Acquisition Station (IMAS) is a PACS and teleradiology software application used to acquire digitized film images, add and modify patient and study demographics, and transmit the results to DICOM PACS systems, archives and workstations. IMAS is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information. Image Medical Acquisition Station (IMAS) is for use in hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information. Lossy compressed mammography images and digitized film screen mammography images must not be reviewed for primary image interpretations. Mammography 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
    IMAS is a software application used to acquire image data from film digitizers and send it to DICOM-compliant devices. IMAS executes on a Microsoft Windows NT, 2000 and XP workstation that is connected to a film digitizer via a SCSI cable. When IMAS initializes, it obtains some settings information from the film digitizer, and displays a user interface. From the user interface, a user logs onto IMAS using an account ID and password. Once logged into IMAS, the user has the ability to create patient and study information, instruct the film digitizer to scan one or more sheets of film and download the image data, group the data from one or more films into a folder, and send the resulting information to one or more configured destinations via DICOM. When IMAS receives the image data from the film digitizer, it appears on the workstation monitor for review. At this point, the user can reorient the image by flipping and rotating it, adjust the window and level setting, or apply a zoom factor to it. If the digitized image is of a sheet of film containing multiple images, the user can separate the image into one or more images by defining the area of each image and creating a new image from the data in the selected area.
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    K Number
    K031778
    Device Name
    PRACTICEBUILDER 1-2-3
    Date Cleared
    2003-08-07

    (58 days)

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

    ERAD IMAGEMEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PracticeBuilder 1-2-3 is a PACS and teleradiology system used to receive DICOM 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. PracticeBuilder 1-2-3 is for use in hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
    Device Description
    PracticeBuilder 1-2-3 is a PACS system, comprised of acquisition components (GatewayServer and SendServer), a central system manager component (SmartServer), a diagnostic workstation component (Workstation and Viewer), and an archiving component (ArchiveServer). 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 worklist. 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 PracticeBuilder 1-2-3's 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. PracticeBuilder 1-2-3 is also a teleradiology system used to receive DICOM 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.
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