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510(k) Data Aggregation

    K Number
    K990560
    Device Name
    LIFE IMAGING SYSTEMS, MODEL L3DI
    Manufacturer
    LIFE IMAGING SYSTEMS, INC.
    Date Cleared
    1999-05-20

    (87 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFE IMAGING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Life Imaging Systems L3Di is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing such as distance, area, volume and angle measurements. It is an add-on accessory for existing ultrasound imaging systems, and is intended to record position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. It is intended as a general purpose digital 3D ultrasound image processing tool for radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, cardiology, obstetrics and gynecology.
    Device Description
    The Life Imaging Systems L3Di is a high performance computer system based on Apple Computer and Windows NT standards. It incorporates a commercially available image digitizer circuit board and proprietary software for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets. The device is an add-on accessory for any existing diagnostic imaging ultrasound system. The device records ultrasound transducer spatial position during use, either with transducer positioner assemblies or with a 6-degree of freedom coordinate tracking system.
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    K Number
    K961403
    Device Name
    LIFE IMAGING SYSTEMS LIS 6000 A
    Manufacturer
    LIFE IMAGING SYSTEMS, INC.
    Date Cleared
    1996-07-03

    (83 days)

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

    LIFE IMAGING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LIS 6000A is intended to acquire a full resolution set of B-Mode images. The source of these images is the analog video or digital video output of a diagnostic ultrasound system. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice). The LIS 6000A is intended to acquire a full resolution set of Color Flow images. The source of these images is the analog video or digital video outputs of a diagnostic ultrasound system. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice). The LIS 6000A is intended to acquire a high resolution set of B-Mode loops. The source of these loops is the analog video or digital video output of a diagnostic ultrasound system. Gating is accomplished by analyzing externally generated cardiac and/or respiratory signals. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice). The LIS 6000A is intended to acquire a high resolution set of Color Flow loops. The source of these loops is the analog video or digital video output of a diagnostic ultrasound system. Gating is accomplished by analyzing externally generated cardiac and/or respiratory signals. Image acquisition excernally generator linear (parallel slice), axial (propeller slice) or sector (fan slice). The LIS 6000 is intended to reformat the acquired B-Mode and Color Flow data sets into a single volumetric data space and subsequently display multiple planar cross sections of that space, either individually, or together in a 3D polyhedral display The LIS 6000A is intended to display three different volumetric rendering display modes: Maximum intensity, surface rendering and volume rendering. The LIS 6000A will make basic distance, area, and volume measurements based on boundaries defined in user selected cross sectional planes.
    Device Description
    The LIS 6000 is a device which can acquire, display, and post process diagnostic ultrasound images. Data acquisition involves video grabbing a set (or sets) of ultrasound frames, each frame representing a planar image, while positioning the ultrasound probe such that the set of 2D planes acquired spans a predefined volume with a known relationship between the planes. The probe positioning devices are described below. Three types of acquisitions are defined for the LIS 6000A: ungated, single phase gated and multiphase gated.
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