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510(k) Data Aggregation

    K Number
    K140033
    Device Name
    TARGET3D FUSION
    Manufacturer
    CONVERGENT LIFE SCIENCES, INC.
    Date Cleared
    2014-02-27

    (51 days)

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

    CONVERGENT LIFE SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    target3D Fusion is a software application intended to be used by physicians in a clinic or hospital for visualization in 2D and 3D, registration, and fusion of Ultrasound (US), Magnetic Resonance (MR) and Computed Tomography (CT) images of the prostate. The software features also include multi-modality data communication, surface and volume rendering, segmentation, multi-planar reconstruction, organ and regions of interest delineation, landmark selection, measurements, patient database management, and data reporting.
    Device Description
    target3D Fusion is a software application, which allows a physician to segment the prostate gland, and identify and label various structures including regions of interest (ROIs) on a pre-procedural DICOM image. The software further allows a physician to fuse the prepared pre-procedural DICOM image files with one or more intra-procedure live DICOM image files to guide the procedure. The software can delineate the gland boundary as well the boundaries of any other anatomical landmarks on a pre-procedure DICOM image. The structures including regions of interest are identified using visualization, and stored as standard surface format meshes. Each such structure is labeled uniquely. target3D Fusion provides a physician with image fusion such that the information from a pre-procedure or planning imaging modality such as MR or CT is mapped to the frame of reference of the intra-procedure or live imaging modality such as ultrasound for real-time guidance while taking advantage of diagnostic capabilities of the pre-procedural planning image. The mapped information contains at least one structural image, and the target area to be treated. The pre-procedure image is registered with the intra-procedure image using a combination of rigid, affine and non-rigid elastic registration provides a correspondence or a deformation map, which is used to map planning information from the frame of reference of the planning image to an intra-procedure image.
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