Regulatory Resources

• provides access through a web browser to visualize (desktop and mobile) and transmit (desktop only) 2D DICOM and non-DICOM images, image derived metadata and derived images. The device does not alter the original image;
• transmits images to be processed by hosted external systems based on user defined routing criteria and external results to user defined groups and systems;
• user controlled optimization of image presentation through zooming, window leveling, panning, filtering and synchronization of images from different series;
• simple quantitative tools for distance, regions of interest and angles. Displayed values are based on the DICOM sizing data provided by the original image, the device makes no claim to the accuracy of the value;
• interaction capabilities for a user to accept or reject metadata;
• provides access to a mobile application where a user can communicate with other users; visualization of images within the mobile application is intended for informational purposes only and is not intended for diagnostic use.

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.

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.

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 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 surgery, 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, Curved MPR, Stretched MPR, MIP, MinIP, Raysum and MAR.
• Capture and Report.

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 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.

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.