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IHE Integration Statements
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DICOM Conformance
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Quality Management System Certificates
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HL7 Conformance Statement
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The Eureka Clinical AI Platform is a software as a medical device to be used in conjunction with other patient information and the judgement of healthcare professionals for accessing and visualizing medical images and image-derived metadata. The device is not intended to provide a diagnosis, measurements nor information which would be used to take a decision. The device offers the following functionality:
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.
IntuitionMOBlLE 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-TDA. TVA. and Parametric Mapping are software modules which supports assessment of time-dependent behavior of image intensity, density. 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 Intuition-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-TIDA, 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-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. The MR 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. Additionally, 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 qualitative results and visualization 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 diagnosis of 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-Structural Heart Module is a software solution that is intended to assist Cardiologists, Radiologists and Clinical Specialists with the visualization and measurements of structures of the heart and vessels.
Intuition-Structural Heart Module enables the user to:
Intuition-Structural Heart Module has the following tools and features that facilitate:
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 used by other 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.
TeraRecon Cardiac.Chambers.MR automatically segments cardiac chambers inner and outer walls of the left ventricle and inner wall of the right ventricle. The input files for the device are contrast or non-contrast images acquired via DICOM complaint MR imaging devices. The outputs are DICOM files that may be utilized by other DICOM-compliant systems and results, such as TeraRecon’s Intuition system or other image viewing systems like PACS.
The TeraRecon Cardiac.Chambers.MR Algorithm results are designed for use by trained healthcare professionals and are intended to assist the physician in diagnosis or treatment planning. The physician is responsible for making all final patient management decisions.
This medical device is intended to segment Cardiac chambers as anatomical structures on contrast or non-contrast MR scans of adult patients that undergo Cardiac MR procedures. The algorithm is not specific to any gender or ethnic group or clinical conditions.
TeraRecon Cardiovascular.Calcification.CT is intended to provide an automatic 3D segmentation of calcified plaques within the coronary arteries and outputs a mask for calcium scoring systems to use for calculations. The results of TeraRecon Cardiovascular.Calcification.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 Cardiovascular.Calcification.CT is a software as a medical device (SaMD) deployed as a containerized application. The device inputs are CT heart without 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 Cardiovascular.Calcification.CT is indicated to generate results from Calcium Score CT scans taken of adult patients, 30 years and older, except patients with pre-existing cardiac devices, electrodes, previous and established ischemic diseases (IMA, bypass grafts, stents, PTCA) and Thoracic metallic devices. The device is not specific to any gender, ethnic group, or clinical condition. The device’s use should be limited to CT scans acquired on General Electric (GE) or Siemens Healthcare or their subsidiaries (e.g. GE Healthcare) equipment. Use of the device with CT scans from other manufacturers is not recommended.
The TeraRecon Neuro Algorithm is an algorithm for use by trained professionals, including but not limited to physicians, surgeons and medical clinicians.
The TeraRecon Neuro 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 TeraRecon Neuro Algorithm provides analysis capabilities for functional, dynamic, and derived imaging datasets acquired with CT or MRI. It can be used for the 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, tissue blood volume, and other parametric maps with or without the ventricles included in the calculation. The algorithm also include volume reformat in various orientation, 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 TeraRecon Neuro Algorithm can be delivered to the end-user through image viewers such as TeraRecon’s Aquarius Intuition system, TeraRecon’s Eureka AI Results Explorer, TeraRecon’s Eureka Clinical AI Platform, or other image viewing systems like PACS that can support DICOM results generated by the TeraRecon Neuro Algorithm.
The TeraRecon Neuro 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.
TeraRecon Headquarters
610 W Germantown Pike,
Plymouth Meeting, PA 19462
info@terarecon.com
All offerings are subject to availability and regulatory clearance, which may vary by country. Please verify product status with your local TeraRecon representative.