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TeraRecon Aorta.CT is intended to provide an automatic 3D segmentation and label anatomical landmarks of the Aorta. The results of TeraRecon Aorta.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care. TeraRecon Aorta.CT is a software as a medical device (SaMD) deployed as a containerized application. The device inputs are CT Angiography with contrast DICOM images. The device outputs are DICOM result files which may be viewed utilizing DICOM-compliant systems. The device does not alter the original input data and does not provide a diagnosis. TeraRecon Aorta.CT is indicated to generate results from aortic CT Angiography scans taken of adult patients except patients with pre-existing aortic device, bicuspid aortic valve anomaly, aortic dissection, aortic rupture, and abdominal metallic devices. The device is not specific to any gender, ethnic group, or clinical condition.

The TeraRecon Aorta.CT algorithm is an image processing software device that can be deployed as a containerized application (e.g., Docker container) that runs on off-the-shelf hardware or on a cloud platform. The device provides an automatic 3D segmentation of the aorta and landmarks of important aortic anatomy. When TeraRecon Aorta.CT results are used in external viewer devices such as TeraRecon's Intuition or Eureka Clinical Al medical devices, all the standard features offered by the external viewer are employed. The TeraRecon Aorta.CT algorithm is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by individuals that have been trained in the software's function, capabilities, and limitations.

The Neuro.AI Algorithm is an algorithm for use by trained professionals, including but not limited to physicians, surgeons and medical clinicians. The Neuro.Al Algorithm is a standalone image processing software device that can be deployed as a Microsoft Windows® executable on off-the-shelf hardware or as a containerized application (e.g., a Docker container) that runs on off-the-shelf hardware or on a cloud platform. Data and images are acquired via DICOM compliant imaging devices. DICOM results may be exported, combined with or utilized by other DICOM-compliant systems and results. The Neuro.AI algorithm provides analysis capabilities for static, functional, dynamic and derived imaging datasets acquired with CT or MRI. It can be used for the analysis of dynamic brain image data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to brain tissue perfusion, vasular assessment and tissue blood volume and other parametric maps with or without the ventricles included in the calculation. The algorithm also includes volume reformat in various orientions, rotational MIP 3D batch while removing the skull. This "tumble view" allows qualitative review of vascular structure in direct correlation to the perfusion maps for comprehensive review. The results of the Neuro.AI Algorithm can be delivered to the end-user through image viewers such as TeraRecon's Aquarius iNtuition system, TeraRecon's Northstar AI Results Explorer, or other image viewing systems like PACS that can support DICOM results generated by Neuro.AI. The Neuro.AI Algorithm results are designed for use by trained healthcare professionals and are intended to assist the physician in diagnosis, who is responsible for making all final patient management decisions.

The Neuro.Al Algorithm is a modification of the predicate device, iNtuition-TDA, TVA, Parametric Mapping which was cleared under K131447. The predicate device is an optional module/workflow for the iNtuition system (K121916). The Neuro.Al Algorithm is a standalone image processing software device that can be deployed as a Microsoft® Windows executable on off-the-shelf hardware or as a containerized application (e.g., Docker container) that runs on off-the-shelf hardware or on a cloud platform. The device has limited network connectivity or external medical support. The Neuro.Al Algorithm allows motion correction and processes, calculates and outputs brain perfusion analysis results for static, functional, dynamic and derived imaging datasets acquired with CT or MRI. Neuro.Al results are used for visualization and analysis of dynamic brain perfusion image data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to brain tissue perfusion, vascular assessment displayed in rotational Maximum Intensity Projection (MIP) called the tumble view, and tissue blood volume and other parametric maps with or without brain ventricles included in the calculation. Outputs include text and parametric map displays of measurements including time to peak (TTP), take off time (TOT), recirculation time (RT), mean transit time (MTT), blood volume (BV/CBV), blood flow (BF/CBF), classification maps, reformatted images and rotational MIPs for 2D and 3D visualization of brain tissues and blood vessels, and for correlation to the perfusion maps. The results of the Neuro.Al Algorithm can be delivered to the end-user through image viewers such as TeraRecon's iNtuition system, TeraRecon's Northstar Al Results Explorer ("Northstar"), or other third-party image viewing systems like PACS that can display the DICOM results generated by Neuro.Al output does not depend on the viewing system's capabilities as the results are self-contained and the only interface is through DICOM. When the Neuro.Al Algorithm results are used on iNtuition, all the standard features offered by iNtuition are employed such as image manipulation tools like drawing the region of interest, manual or automatic segmentation of structures, 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. The Neuro.Al algorithm can be used by physicians to aid in the diagnosis. The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by individuals that have been trained in the software's function, 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-TDA, TVA, and Parametric Mapping are software modules which supports assessment of time-dependent behavior of image intensity, dimensions or volume of regions of interest over time, for volumetric or planar dynamic image types such as CT or MR. Parametric mapping tools encode in color various parameters derived from the temporal or spatial characteristics of the planar or volumetric data. Support is provided for digital image processing to derive metadata or new images from input image sets, for internal use or for forwarding to other devices using the DICOM protocol. Image processing tools are provided to extract metadata to derive parametric images from combinations of multiple input images. iNtuition-TDA, TVA and Parametric Mapping are iNtution based software features with dedicated workflows and basic tools and thus support post-processing, displaying and manipulation of reports and medical images from acquisition devices and visualization in 2D, 3D and 4D for single or multiple datasets, or combinations thereof. iNtuition-TDA, TVA, Parametric 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 - TDA. IVA. Parametric Mapping are post-processing modules, part of iNtuition, which is a software device generally used with 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, all, or none of its optional features disabled. A fully-configured iNtuition system is capable of various image processing and visualization functions to support the physician in medical image reviewing. iNtuition - TDA, TVA, Parametric Mapping intended used is to provide solutions to various medical image analysis and viewing problems, which come about as modalities generate more and more images. They also support image distribution over networks, and are DICOM compliant. iNtuition Time-Dependent Analysis (TDA) and Time-Volume Analysis (TVA) features can obtain quantitative information relating to the evolution of the intensity, density or dimensions of certain regions of CT. MR or other images over time. Statistical analysis such as a histogram representation of the image density values in an image is supported, and analysis of changes in volume over time from multi-phase volumetric images; for example, eiection fraction and stroke volume measurement calculation can be performed using the Time-Volume Analysis tools. iNtuition Parametric Mapping tools encode in color various parameters derived from the temporal or spatial characteristics of the planar or volumetric data. iNtuition - TDA, TVA and Parametric Mapping are iNtuition-based optional features, and employ all standard features offered by iNtuition, such as convenient tools to support creation of a report, transmitting and storing this report in digital form, and tracking historical information about the studies analyzed with the software. These three modules can be sold separately or as a part of the bigger iNtuition package.

To receive, store, transmit, post-process, display and allow manipulation of reports and medical images from acquisition devices, including optical or other non-DICOM format images. DICOM images with modality type XA, US, CR, DR, SPECT, NM and MG, and images from volumetric medical scanning devices such as EBT, CT, PET or MRI. To provide access to images derived data and derived images via client-server software, web browser and mobile technology. Visualization in 2D, 3D and 4D are supported for single or multiple datasets, or combinations thereof. Tools are provided to define and edit paths through structures such as centerlines, which may be used to analyze cross-sections of structures, or to provide flythrough visualizations rendered along such a centerline. Segmentation of regions of interest and quantitative analysis tools are provided, for images of vasculature, pathology and morphology, including distance, angle, volume, histogram, ratios thereof, and tracking of quantities over time. A database is provided to track and compare results using published comparison techniques such as RECIST and WHO. Calcium scoring for quantification of atherosclerotic plaque is supported. Support is provided for digital image processing to derive metadata or new images from input image sets, for internal use or for forwarding to other devices using the DICOM protocol. Image processing tools are provided to extract metadata to derive parametric images from combinations of multiple input images, such as temporal phases, or images co-located in space but acquired with different imaging parameters, such as different MR pulse sequences, or different CT image parameters (e.g. dual energy). iNtuition is designed for use by healthcare professionals and is intended to assist the physician in diagnosis, who is responsible for making all final patient management decisions. Interpretation of mammographic images or digitized film screen images is supported only when the software is used without compression and with an FDA-Approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA. iNtuitionMOBILE provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. Not intended for diagnostic use when used via a web browser or mobile device.

iNtuition is a software device generally used with 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 described elsewhere in this document. The system 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 (with conference capabilities). iNtuition supports the physician in medical image viewing. A fully-configured iNtuition system is capable of various image processing and visualization functions, including full-color Volume Rendering, Calcium Scoring, Segmentation Analysis and Tracking (SAT), Vessel Analysis, Flythrough, Multi-phase review, CT/ CTA Subtraction, Lobular Decomposition (LD), iGENTLE, Maxillo-Facial, Volumetric Histogram, Findings Workflow, Fusion CT/ MR/ PET/ SPECT, MultiKV etc. Each of these features may be offered as an independent upgrade option to the basic configuration. The intended use of the device is to provide solutions to various medical image analysis and viewing problems, which come about as modalities generate more and more images. It also supports image distribution over networks, and is DICOM compliant.

The AquariusAPS server receives medical images from medical imaging acquisition devices adhering to the DICOM protocol for image transfer such as EBT, CT, MRI, and other volumetric or planar medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

The AquariusAPS server receives medical images from medical imaging acquisition devices adhering to the DICOM protocol for image transfer such as EBT, CT, MRI, and other volumetric or planar medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA." The intended use of the device is to provide time-saving pre-processing of images to remove the need for an image review system to perform these activities while a user is waiting for processing to complete, to optimize the use of the user's time. The AquariusAPS Server utilizes standard "off the shelf" personal computer systems as its hardware platform. The software requires the use of the Windows 2000 operating system, and a Pentium III - class processor or equivalent.

The AquariusNET Server acquires, stores, transmits, and enables compatible computers on a network to display medical images from medical scanning devices and patient reports of various types. Teleradiology, such as MRI, CT or NM and archiving, image manipulation, 3D and 4D visualization are supported. Calcium scoring from whole body computed tomography derived measurements, for non-invasive detection and quantification of atherosclerotic plaque. Tools for histogram analysis of the density distribution of certain regions of interest are provided. A database management and report generation tool is included.

AquariusNET is a device consisting of a DICOM server that receives and stores images from a PACS or other image giving modalities. It archives images in a scalable storage medium and delivers them in response to DICOM Query/Retrieve requests from other DICOM devices on the network (not part of AquariusNET). It also serves image requests to its remote "thin clients", which act as the graphical user interface to the AquariusNET server. The server can host multiple concurrent sessions from remote "thin clients". AquariusNET features an integrated 2D/3D streaming engine which allows regular PCs or notebooks to control the server, and to review 2D images and 3D reconstructions interactively over a network. AquariusNET is capable of image review, communications, archiving, database maintenance, reporting and basic 3D capabilities described elsewhere in this document. It is also capable of full-color Volume Rendering and Calcium Scoring.

Acquire, store, transmit, and display medical images and patient reports of various types. Teleradiology image acquisition, distribution, archive and viewing.

The IiVS™ Integrated image Viewing Station is a product family, which comes in two different versions: DiVS: a DICOM viewer IiVS: a 3D viewer. The intended use of the devices is to provide solutions to various medical image-viewing problems, which come about as the modalities generate more and more images. They also support image distribution over networks, and are DICOM conformant. Finally, the IIVS™ Integrated image Viewing Station family supports the radiologist in writing a report, and transmitting and storing this report in digital form.

The TeraRecon RTR-2000 Image Reconstruction System should be used when it is desirable to view scanned medical images immediately, rather than wait long periods of time for reconstruction. Indications would include monitoring of radiological examinations for patient movement. It is possible that patient movement during the middle of an examination, which may require re-scanning, would not be detected until after the completion of the exam when all of the images are reconstructed and thus visualized. High speed image reconstruction allows for real-time visualization of the images. Such real-time visualization of images gives the immediate visual feedback necessary to monitor the progress of examinations in efforts to maximize scanning accuracy and minimize radiation dose to the patient. In short, real-time visualization of images is indicated in cases where the user prefers immediate visual feedback as opposed to having to wait long periods of time for image reconstruction.

The TERARECON, INC. RTR-2000 real-time image reconstruction system acquires medical image data from such medical imaging devices as CT and reconstructs the "raw" data into visible images. The RTR-2000 system reconstructs images with such high performance that the images This stand-alone high performance image are viewed in real-time. reconstruction system is offered as an upgrade to existing imaging devices, and is not intended to replace the devices' existing reconstruction system. Rather, it is intended to serve as an alternative means of viewing medical images, particularly where real-time visualization of images is beneficial.