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510(k) Data Aggregation

    K Number
    K974755
    Device Name
    DYNA VUE 3-D IMAGING PRODUCT
    Manufacturer
    Date Cleared
    1998-03-04

    (75 days)

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

    IMD SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device will be used in the same manner as all three dimensional imaging products are used, similar to the Voxel System. It can be used with any two and three dimensional spinning image data such as MRI, CAT, DSA and Ultrasound produced data and converts the data into complete and real 3D images in rotational and static fashion. The device is used to aid the surgeon by permitting more precise morphological diagnosis especially in aneurysms, atherosclerotic lesions and bile duct carcinomas due to the improved view of the data. It may also facilitate highly selective interventional procedures for vascular surgeons because of the improved three dimensional vascular road map the physician sees. The system does not take the place of the physician it is only a tool to assist the physician in his diagnosis, it does not make the diagnosis for him. Decisions about what to do and how to perform a procedure rest firmly with the physician. This device is used primarily by physicians and health care workers, and is normally used under the supervision of a physician. It is not sold to the general public but may be available as a teaching tool to Universities and Medical Schools without the requirement of physician supervision.
    Device Description
    The DynaVue 3-D spinning Image System (3DSI) takes a stream of images (frames) and as a first step duplicates the frames and pairs them by delaying one image stream. This is done by the 3DSI's field delay circuit. With the paired image, the system has now created a parallax. In order to see a 3-D image the system creates a sequence of left or right images on the screen. After the paired images are coded " left" and " right", the information is transmitted to a controller/emitter. The emitter converts the left and right information into an infrared signal which activates the left or right shutter. The emitted 3-D images are observed with active viewing eyewear. The system can also be used with an active monitor screen, the same principles as above apply except that the infrared emitter is not needed and the active viewing evewear is replaced by passive polarizing glasses.
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