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iNtuition-Structural Heart Module is a software solution that is intended to assist Cardiologists, and Clinical Specialists with the visualization and measurements of the heart and vessels. iNtuition-Structural Heart Module enables the user to: - · Visualize and measure (diameters, lengths, angles, areas and volumes) structures of the heart and vessels for pre-operative planning and sizing for cardiovascular interventions and for post-operative evaluation. - · Quantify calcium (volume, density) iNtuition-Structural Heart Module has the following tools and features that facilitate: - · Automatic and manual centerline detection. - · Segmentation of cardiovascular structures. - · Measurement tools (diameters, lengths, areas, volumes, angles) for the dimensions of vessels and structures. - · Calcium quantification and scoring. - · Various visualization techniques: 2D/3D/4D visualization, MPR, Stretched MPR, MIP, MinlP, Raysum and MAR. - · Capture and Report.

iNtuition-Structural Heart Module is an optional image post-processing software module using iNtuition (K121916) standard features and part of its optional features. It is a software device generally used with the off-the-shelf hardware, offered in various configurations, with the simplest configuration being a stand-alone workstation capable of image review, communications, archiving, database maintenance, remote review, reporting and basic 3D capabilities. It can also be configured as a server with some, or with all, or none of its optional features. Whether provided as a workstation or a server, the iNtuition-Structural Heart Module software is designed to provide access by a local user physically sitting at the computer hosting the iNtuition server software, and/or by one or more remote users who concurrently connect to the server using a freely-downloadable thin client application or through a zero-footprint web viewer (with conference capabilities) over local network or internet. iNtuition-Structural Heart Module is iNtuition (K121916) based optional feature and employs all standard features offered by iNtuition such as convenient image manipulation tools like drawing of region of interests, manual and automatic segmentation of structures, image assessment and measurement tools - linear, diameter, angle, area and volume and tools that support the creation of reports, transmitting and storing this report in digital form and tracking historical information about the studies analyzed by the software. iNtuition Vessel analysis and calcium scoring features are utilized to support automatic and manual centerline extraction and analysis and calcium quantification. iNtuition-Structural Heart Module: - . Supports the visualization and quantification of coronary vessels and cardiac structures for anatomic and pre- or post-operative evaluations through guided clinical workflows. - . Enables the assessment and measurement of different structures of the heart, e.g. aorta, aortic valves, mitral valve, pulmonic valve, atria and atrial appendages, and ventricles. - . Provides analysis of the feasibility of a transapical, transfemoral or subclavian approach to structures for replacement or repair procedures via 3D measurements. - Uses the same iNtuition (K121916) Vessel Analysis and Calcium modules.Enables . assessment and measurement of vessels and can help identify calcifications, aneurysms and other anomalies to quickly and reliably prepare for various types of vascular procedures.Supports the creation, transmission and storage of a report in digital form. It can also track historical information about the studies analyzed by the software.Displays results analysis, that can be printed as hardcopy or saved in a variety of formats to a hard disk, network, PACS system or CD/DVD/USB.

iNtuition-T1 Mapping and T2/T2* Mapping are software modules that support the derivation and quantification of T1, T2 and T2* values from MR DICOM image pixel intensities and header information. The quantification of these parameters can be used to characterize tissues. Support is provided to overlay the T1, T2, and T2* values using colormaps on related MR images. Support is provided for using different colormaps to overlay different ranges of T1, T2 or T2* values and restrict the overlay to region of interest on the images can be of simple planar scan like a single slice or volumetric or 4D scans of a body part. iNtuition-T1 Mapping and T2/T2* Mapping are iNtuition software features that can be used in multiple workflows or be used as basic tools for cardiac functionality, the overlaid images can be captured and forwarded to other systems using standards such as DICOM or http protocol. Quantitative analysis is derived and available as text and graphical display. iNtuition- T1 Mapping and T2/T2* Mapping qualitation can be used in a clinical setting on MR images of an individual patient and can be used to support the clinical decision making for the patient. iNtuition- T1 Mapping and T2/T2* Mapping are designed for use by healthcare professionals and are intended to assist the physician in diagnosis, who is responsible for making all final patient management decisions.

iNtuition-T1 Mapping and T2/T2* Mapping is an optional image post-processing module, part of iNtuition (K121916), which is software only device generally used with the off-the-shelf hardware, offered in various configuration, with the simplest configuration being a stand-alone workstation capable of image review, communications, archiving, database maintenance, remote review, reporting and basic 3D capabilities. It can also be configured as a server with some, all, or none of its optional features disabled. Whether provided as a workstation or a server, the iNtuition software is designed to provide access by a local user physically sitting at the computer hosting the iNtuition server software, and/or by one or more remote users who concurrently connect to the server using a freely-downloadable thin client application or through a zero-footprint web viewer (with conference capabilities) over local network or internet. iNtuition-T1 Mapping and T2/T2* Mapping feature can derive quantitative values from intensities and header information of specific MR scan sequences that are specifically coded to enable such derivation (such as Look-Locker and MOLLI for T1.) The quantification of these parameters can be used to derive clinical value such as T2*.. Post-processing such as computation of statistics like volume, area, min/max or various combinations of the derived values, over regions of interests or overlay the derived values using a colormap on related images or a region of the images. The region of interests can be defined by the user through manual, semi-automatic or automatic segmentation techniques provided by iNtuition. The derivation and post-processing can be used with planar, volumetric or 4D scan sequences for cardiac functionality. iNtuition-T1 Mapping and T2/T2* Mapping is an iNtuition based optional features, and employ all standard features offered by iNtuition such as convenient image manipulation tools like drawing region of interest, manual or automatic segmentation of structures and tools that support creation of a report, transmitting and storing this report in digital form, and tracking historical information about the studies analyzed by the software. This device is intended only to assists the operator in making decisions. The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people that have been trained in the software's function (iNtuition), capabilities and limitations. The device is intended to provide supporting analytical tools to a physician, to speed decision-making and to improve communication, but the physician's judgment is paramount and it is normal practice for physicians to validate theories and treatment decisions multiple ways before proceeding with a risky course of patient management. iNtuition-T1 Mapping and T2/T2* Mapping modules may be sold separately or as an extension of iNtuition.