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Simplicit90Y is a standalone software device that is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. Simplicit90Y supports the reading and display of a range of DICOM compliant imaging and related formats including but not limited to CT, PT, NM, SPECT, MR, SC, RTSS. Simplicit90Y enables the saving of sessions in a proprietary format as well as the export of formats including CSV and PDF files. Simplicit90Y is indicated, as an accessory to TheraSphere®, to provide pre-treatment dosimetry planning support including Lung Shunt Fraction estimation (based on planar scintigraphy) and liver single-compartment MIRD schema dosimetry, in accordance with TheraSphere® labelling. Simplicit90Y provides tools to create, transform, and modify contours/Regions of Interest for calculation of Lung Shunt Fraction and Perfused Volume. Simplicit90Y includes features to aid in TheraSphere® dose vial selection, dose vial ordering and creation of customizable reports. Simplicit90Y is indicated for post-treatment dosimetry and evaluation following Yttrium-90 (Y-90) microsphere treatment. Simplicit90Y provides tools to create, transform, and modify contours/Regions of Interest for the user to define objects in medical image volumes to support TheraSphere® post-Y-90 treatment calculation. The objects include, but are not limited to, tumors and normal tissues, and liver volumes. Simplicit90Y is indicated for registration, fusion display and review of medical mages allowing medical professionals to incorporate images, such as CT, MRI, PET, CBCT and SPECT in TheraSphere® Yttrium-90 (Y-90) microspheres pretreatment planning and post-Y-90 treatment evaluation. For post-Yttrium-90 (Y-90) treatment, Simplicit90Y should only be used for the retrospective determination of dose and should not be used to prospectively calculate dose or for the case where there is a need for retreatment using Y-90 microspheres.

Simplicit®Y is a software device which provides features and tools for use in pre-treatment dosimetry planning of TheraSphere® Y-90 microspheres treatment and post-treatment evaluation of Y-90 microspheres treatment and operates on Windows computer systems. Simplicit®Y pre-treatment dosimetry planning features include Lung Shunt Fraction estimation (based on planar scintigraphy) and liver single-compartment MIRD schema in accordance with TheraSphere® labelling. Simplicit®Y additionally provides tools to support TheraSphere® dose vial selection, dose vial ordering and includes the creation of customizable reports. After administration of Y-90 microspheres, Simplicit®V provides post-treatment dosimetry evaluation with multi-compartment and voxel-wise MIRD techniques applying the Local Deposition Model with scaling for known injected activity to assist the clinician in performing assessment of treatment efficacy and quality assurance, including assessment of absorbed dose to structures such as liver, lung and tumors. Simplicit®Y provides 2D and 3D image display and advanced dosimetry analysis tools including isodose contour line plan and dose volume histograms. Simplicit®9Y provides tools for multi-modal image fusion using rigid and deformable registration capable of manual, semi-automated and fully automated operation. Simplicit90Y includes evaluation tools for assessment of registration quality. Simplicit®9Y provides semi-automated and automated tools for segmentation of Region/Volume Of Interest on multi-modal images. Simplicit®Y supports the reading, rendering and display of a range of DICOM compliant imaging and related formats including but not limited to CT, PT, NM, SC, RTSS. Simplicit90Y enables the saving of sessions in a proprietary format as well as the export of RTSS, CSV and PDF files. Simplicit®Y should not be used to change a treatment plan after treatment has been delivered with Yttrium-90 (Y-90) microsphere implants.

Workflow Box is a software system designed to allow users to route DICOM-compliant data to and from automated processing components. Supported modalities include CT, MR. RTSTRUCT Workflow Box includes processing components for automatically contouring imaging data using deformable image registration to support atlas based contouring of the same patient and machine learning based contouring. Workflow Box is a data routing and image processing tool which automatically applies contours to data which is sent to one or more of the included image processing workflows. Contours generated by Workflow Box may be used as an input to clinical workflows including, but not limited to, radiation therapy treatment planning. Workflow Box must be used in conjunction with appropriate software to review and edit results generated automatically by Workflow Box components, for example image visualization software must be used to facilitate the review and edit of contours generated by Workflow Box component applications. Workflow Box is intended to be used by trained medical professionals. Workflow Box is not intended to automatically detect lesions.

Workflow Box is a software application that enables the routing of image data and structures to automatic image processing workflows, including atlas based contouring, image registration based re-contouring and machine learning based contouring. Workflow Box data routing and contouring workflows support CT, MR and RTSTRUCT image data and structures. Workflow Box supports the routing of data to and from DICOM nodes within a hospital network. Once data is routed to the auto contouring workflows there is no user interaction required and no user interface for visualizing image data. The configuration of workflows and data routing rules are managed via an administration interface. Workflow Box must be used in conjunction with appropriate software to review and edit results generated automatically by Workflow Box components. Image visualization software, such as a treatment planning system, must be used to facilitate the review and edit of contours generated by Workflow Box component applications.

LMS is indicated for use as magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LMS is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from Siemens MAGNETOM Skyra MR Scanners, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LMS provides a number of quantification tools such as rulers and region of interest to be used for the assessment of regions of an image to support existing clinical workflows. These images and the physical parameters derived from the images, when interpreted by a trained physician, yield information that may assist in diagnosis.

LiverMultiScan (LMS) is a standalone software application for displaying 2D Magnetic Resonance medical image data acquired from Siemens MAGNETOM Skyra MR Scanners. LMS runs on a workstation with color monitor, keyboard and mouse. LMS is designed to allow the review of DICOM 3.0 compliant datasets stored on the workstation and the user may also create, display, print, store and distribute reports resulting from interpretation of the datasets. LMS allows the display and comparison of combinations of magnetic resonance images and provides a number of tools for the quantification of magnetic resonance images, including the determination of triglyceride fat fraction in the liver. LMS provides a number of tools such as rulers and circular region of interest to be used for the assessment of regions of an image to support a clinical workflow. LMS allows users to create relaxometry parameter maps of the abdomen which can be used by clinicians to help determine different tissue characteristics to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of liver fat. LiverMultiScan (LMS) is intended to be used by trained healthcare professionals including, but not limited to, radiologists, gastroenterologists, radiographers and physicists. LiverMultiScan is an aid to diagnosis. When interpreted by a trained physician, the results provide information, which may be used as an input into existing clinical procedures and diagnostic workflows. LiverMultiScan offers: - . Advanced visualization of MR data - . Processing of MR data to quantify tissue characteristics including MR Relaxivity constants such as T2*, T1. cT1 and liver fat percentage - . Circular Region of interest statistics - Snapshot of images to include in a report - Report to include region statistics, snapshot images and user-entered text - Export of snapshot images and report to storage - . Integration with Mirada DBx – a software module that maintains a local temporary cache of DICOM data and can interact with PACS, from which it can receive data Mirada DBx is a medical device data system (MDDS, product code OUG, regulation number 880.6310) used for DICOM connectivity with other systems. - Ability to send data from Mirada DBx to PACS or other DICOM nodes for archive and distribution

RTx is intended to be used by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, radiation oncologists, dosimetrists and physicists. RTx is a software application intended to display and visualize 2D & 3D multi-modal medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities include static and gated CT, PET, MR, SPECT and planar NM. The user may also create, display, print, store and distribute reports resulting from interpretation of the datasets. RTx allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison of image data by the user. The result of the registration operation can assist the user in assessing changes in image data, either within or between examinations and aims to help the user obtain a better understanding of the combined information that would otherwise have to be visually compared disjointedly. RTx provides a number of tools such as rulers and region of interests, which are intended to be used for the assessment of regions of an image to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of lesions, determination of treatment response and follow-up. RTx supports the loading and saving of DICOM RT objects and allows the user to define, import, display, transform, store and export such objects including regions of interest structures and dose volumes to radiation therapy planning systems. RTx allows the user to transform regions of interest associated with a particular imaging dataset to another, supporting atlas-based contouring and rapid re-contouring of the same patient.

RTx is a software application for displaying and visualizing 2D & 3D multi-modal medical image data such as static and gated CT, PET, MR, SPECT and planar NM. RTx runs on a workstation with color monitor(s), keyboard, mouse and optional CD-RW or may be deployed on a server. RTx is designed to enable rendering, reviewing, storing, printing and distribution of DICOM 3.0 compliant datasets and reports within the system and/or across computer networks. RTx enables automatic and manual registration of combinations of anatomical and functional images that can be displayed with fused and non-fused displays to facilitate the comparison of image data by the user. RTx provides a number of tools such as rulers and semi-automated and manual regions of interest for the assessment of regions of an image to support a clinical workflow. RTx supports the loading and saving of DICOM RT objects and allows the user to define, import, display, transform and store and export such objects including regions of interest structures and dose volumes to radiation therapy planning systems.

Mirada RT is intended to be used by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, and physicists. Mirada RT is a software application intended to display and visualize 2D & 3D multi-modal medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities include, static and gated CT and PET, and static MR, SPECT and planar NM. The user may also create, display, print, store and distribute reports resulting from interpretation of the datasets. Mirada RT allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison of image data by the user. The result of the registration operation can assist the user in assessing changes in image data, either within or between examinations and aims to help the user obtain a better understanding of the combined information that would otherwise have to be visually compared disjointedly. Mirada RT provides a number of tools such as rulers and region of interests, which are intended to be used for the assessment of regions of an image to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of lesions, determination of treatment response and follow-up. Mirada RT allows the user to define, import, transform and store and export regions of interest structures and dose volumes in DICOM RT format for use in radiation therapy planning systems.

Mirada RT is a software application for displaying and visualizing 2D & 3D multi-modal medical image data such as static and gated CT and PET, and static MR, SPECT and planar NM. Mirada RT runs on a workstation with color monitor(s), keyboard, mouse and optional CD-RW. Mirada RT is designed to enable rendering, reviewing, storing, printing and distribution of DICOM 3.0 compliant datasets and reports within the system and/or across computer networks. Mirada RT enables automatic and manual registration of combinations of anatomical and functional images that can be displayed with fused and non-fused displays to facilitate the comparison of image data by the user. Mirada RT provides a number of tools such as rulers and region of interests through SUV calculation for the assessment of regions of an image to support a clinical workflow. Mirada RT allows the user to define, import, transform and store and export regions of interest structures and dose volumes in DICOM RT format for use in radiation therapy planning systems.

Mirada XD is intended to be used by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, and physicists. Mirada XD is a software application intended to display and visualize 2D & 3D multi-modal medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities include, CT, MR, PET, SPECT and planar NM. The user may also create, display, print, store and distribute reports resulting from interpretation of the datasets. Mirada XD allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison of image data by the user. The result of the registration operation can assist the user in assessing changes in image data, either within or between examinations and aims to help the user obtain a better understanding of the combined information that would otherwise have to be visually compared disjointedly. Mirada XD provides a number of tools such as rulers and region of interests, which are intended to be used for the assessment of regions of an image to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of lesions, determination of treatment response and follow-up. Mirada XD allows the user to define, transform and export regions of interest structures in DICOM format including RT format for use in radiation therapy planning systems.

Mirada XD is a software application for displaying and visualizing 2D & 3D multi-modal medical image data such as CT, MR, PET, SPECT and planar NM. Mirada XD runs on a workstation with color monitor(s), keyboard, mouse and optional CD-RW. Mirada XD is designed to enable rendering, reviewing, storing, printing and distribution of DICOM 3.0 compliant datasets and reports within the system and/or across computer networks. Mirada XD enables automatic and manual registration of combinations of anatomical and functional images that can be displayed with fused and non-fused displays to facilitate the comparison of image data by the user. Mirada XD provides a number of tools such as rulers and region of interests through SUV calculation for the assessment of regions of an image to support a clinical workflow. Mirada XD also allows users to define, transform, store and export regions of interest structures in DICOM format including RTSS format for use in radiation therapy planning systems.