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510(k) Data Aggregation

    K Number
    K082341
    Device Name
    DSA 2000EX
    Manufacturer
    EIGEN LLC
    Date Cleared
    2008-08-29

    (14 days)

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

    EIGEN LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSA 2000ex device is used in vascular imaging applications. During X-ray exposures, the DSA 2000ex is used to acquire video images from the video display chain provided by the X-ray manufacturer's system. The images are stored in the DSA 2000ex solid state memory, and written to the hard disk medium. Images are processed in real-time to provide increased image usability. The processing is primarily subtraction, but also includes window and level adjustments, as well as optional noise reduction, landscaping, image rotation and pixel shifting. The Eigen DSA 2000ex device is used in X-ray cardiology and radiology labs to enhance diagnostic capabilities of radiologists, and cardiologists, with minimal intervention required by users to perform basic capture, playback, and archiving functions. Additional functions include allowing measurements to be made for quantizing stenosis and guidance of catheters in the Roadmapping mode.
    Device Description
    The DSA 2000ex device is used in vascular imaging applications. During X-ray exposures, the DSA 2000ex is used to acquire video images from the video display chain provided by the X-ray manufacturer's system. The images are stored in the DSA 2000ex solid state memory, and written to the hard disk medium. Images are processed in real-time to provide increased image usability. The processing is primarily subtraction, but also includes window and level adjustments, as well as optional noise reduction, landscaping, image rotation and pixel shifting. The Eigen DSA 2000ex device is used in X-ray cardiology and radiology labs to enhance diagnostic capabilities of radiologists, with minimal intervention required by users to perform basic capture, playback, and archiving functions. Additional functions include allowing measurements to be made for quantizing stenosis and guidance of catheters in the Roadmapping mode.
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    K Number
    K081093
    Device Name
    3-D IMAGING WORKSTATION
    Manufacturer
    EIGEN LLC
    Date Cleared
    2008-05-01

    (14 days)

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

    EIGEN LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3-D Imaging Workstation is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement and 3-D image registration.
    Device Description
    The 3-D Imaging Workstation is designed to display the 2-D live video received from commercially available ultrasound machines and use this 2-D video to reconstruct a 3-D ultrasound image. The system has been designed to work with the clinicians' existing ultrasound machine, end fire TRUS probe, commercially available needle guide and needle gun combination. Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurement and 3-D image registration. The 3-D Imaging Workstation is comprised of a mechanical assembly that holds the ultrasound probe and tracks probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. The mechanical tracker is connected to a PC-based workstation containing a video digitizing card and running the image processing software. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of the 3-D Imaging Workstation. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, the workstation is able to reconstruct and display a 3-D image and 3-D rendered surface model of the prostate. The reconstructed 3-D image can be further processed to perform various measurements including volume estimation, and can be examined for abnormalities by the physician. Patient information, notes, and images may be stored for future retrieval. Locations for biopsies may be selected by the physician, displayed on the 3-D image and 3-D rendered surface model, and stored. Previously stored 3-D models may be recalled and a stored 3-D model may be aligned or registered to the current 3-D model of the prostate. Finally, the physician may attach a commercially available biopsy needle guide to the TRUS probe and use the probe and biopsy needle to perform tissue biopsy. Whenever the ultrasound machine is turned on by the physician, the live 2-D ultrasound image is displayed on the screen of 3-D Imaging Workstation during the biopsy. As the TRUS probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe is tracked. The 3-D Imaging Workstation is able to add, display and edit plans for biopsy sites as well as an estimate of the probe position and needle trajectory relative to the 3-D image and 3-D rendered surface model of the prostate. The 3-D Imaging Workstation offers the physician additional 3-D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe based procedures, and the physician always has access to the live 2-D ultrasound image during prostate assessment or biopsy procedure.
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