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Spectrum Dynamics Medical's VERITON system is intended for use by trained healthcare professionals to aid in the detection, localization, diagnosis, staging and restaging of lesions, diseases, and organ function. For evaluating diseases and disorders such as cardiovascular disease, neurological disorders, and trauma. System outcomes can be used to plan, guide, and monitor therapy. SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: whole body and tomographic imaging. CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes take at different angles. SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.

The VERITONCT 300/400 Series consist of back - to - back Single Photon Emission Computed Tomography (SPECT) and X-Ray Computed Tomography (CT) scanners. The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates CT's anatomical detail for precise reference of the location of the metabolic activity. CT subsystem produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as standalone diagnostic imaging devices. All models employ a same software version 2.3.0 The proposed series consists of four variations: | | Energy range | Integrated CT | |----------------|--------------|---------------| | VERITON CT 316 | 40-300 keV | 16 Slices | | VERITON CT 364 | 40-300 keV | 64 Slices | | VERITON CT 416 | 40-400 keV | 16 Slices | | VERITON CT 464 | 40-400 keV | 64 Slices | Modifications in VERITON Family include: Enhanced CZT module's introduction to support an extended energy range

TruSPECT is intended for acceptance, display, storage, and processing of images for detection of radioisotope tracer uptakes in the patient's body. The device using various processing modes supported by the various clinical applications and various features designed to enhance image quality. The emission computerized tomography data can be coupled with registered and/or fused CT/MR scans and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes. The acquired tomographic image may undergo emission-based attenuation correction. Visualization tools include segmentation, colour coding, and polar maps. Analysis tools include Quantitative Perfusion SPECT (QPS), Quantitative Gated SPECT (QGS) and Quantitative Blood Pool Gated SPECT (QBS) measurements, Multi Gated Acquisition (MUGA) and Heart-to-Mediastinum activity ratio (H/M). The system also includes reporting tools for formatting findings and user selected areas of interest. It is capable of processing and displaying the acquired in traditional formats, as well as in three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs. TruSPECT is based on Windows operating system. Due to special customer requirements and the clinical focus the TruSPECT can be configured with different combinations of Windows OS based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages. TruSPECT is a processing workstation primarily intended for, but not limited to cardiac application can be integrated with the D-SPECT cardiac scanner system or used as a standalone post-processing station.

The TruSPECT is a Nuclear Medicine Software system designed for nuclear medicine images' post processing and further review procedures for detection of the radioisotope tracer uptake in the patient's body. Thus, using a variety of post processing features oriented to specific clinical applications. SUMO Workflow enables visual evaluation and assessment of the sympathetic innervation system of the heart by quantification of uptake ratios between regions of interest, identifying discreet uptake areas of AdreViewtm (lobenguane 123 Injection) or similar agents within the heart. The results generated by the SUMO workflow can be displayed on the D-SPECT processing station and additionally, can be exported to EP systems. It can also be used by the physician to aid in ablation treatment planning by electrophysiologists. D-SPECT Dynamic CFR is a workflow for visualization, and quantification of specific areas of attention. It is capable of processing and displaying the acquired information in traditional formats, as well as in three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs providing quantitative blood flow measurements of SPECT images. The application provides visualization and measurement tools for both qualitative and quantitative visualization and input data evaluation. It provides automated and manual tools for orientation and segmentation of the myocardium. The software calculates myocardial blood flow measurements and provides tools, such as a database comparison workflow, to the clinician to evaluate these outcomes. TruSPECT CT based Attenuation Correction (CTAC) is an application that removes soft tissue artifacts from SPECT images. The goal is to minimize the impact of attenuation to provide more consistent and reliable reading images. The CT Attenuation Correction (CTAC) uses a second form of imaging (CT) to develop a density map of each patient and correct the SPECT image accordingly. TruCorr enhances the user's ability to visualize the acquired information (by way of a single clear image) - thus optimizing what would otherwise be a disjointed visual comparison. It is an Emission Based attenuation correction application using the deep learning model which was trained to directly estimate attenuation corrected SPECT images from non-attenuation corrected ones without the use of any anatomical images.

The Spectrum Dynamics Medical's VERITON™ CT is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and trauma. The system output can be used for planning, guiding, and monitoring therapy. SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques; whole body and tomographic imaging. CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes take at different angles. The CT part is indicated for pediatric and adult patients. SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.

VERITON® CT consists of Single Photon Emission Computed Tomography (SPECT) scanners and integrated X-Ray Computed Tomography (CT). The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates the CT's anatomical details for precise reference of the location of the metabolic activity. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as stand- alone diagnostic imaqing devices.

The Spectrum Dynamics Medical's VERITON™ CT is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and trauma. The system output can be used for planning, guiding, and monitoring therapy. SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques; whole body and tomographic imaging. CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes take at different angles. The CT part is indicated for pediatric and adult patients. SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.

VERITON™ CT consists of Single Photon Emission Computed Tomography (SPECT) scanners and integrated X-Ray Computed Tomography (CT). The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates the CT's anatomical details for precise reference of the location of the metabolic activity. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as stand- alone diagnostic imaging devices.

VERITON™ NM is a Nuclear Medicine (NM) imaging system, intended to perform general nuclear medicine imaging procedures for the detection of radioisotope tracer uptake in a patient's body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. Scanning modes include whole body and tomographic (static, dynamic and multi-gated) mode, while acquisition types include single and multi-isotope single-photon imaging-enhancement features include gating by way of physiological signals and real-time automatic body contouring. The VERITON™ NM system is a medical device intended for use by appropriately-trained healthcare professionals to aid in the detection, localization and diagnosis of diseases and organ function, for the evaluation of diseases, trauma, abnormalities and disorders. System output can be used by a physician for planning, guiding, and monitoring therapy. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: whole body imaging and tomographic imaging. Software: System application software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, CT and other imaging modalities.

Spectrum Dynamics VERITON™ NM system is a single photon emission computing tomography system (SPECT) intended for detection of radioisotope tracer uptake in the body and to produce cross-sectional images through computer reconstruction of the data. The system uses a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The system may utilize various modalities to create attenuation corrected images along with functional and anatomical mapping imaging (localization, registration and fusion). The VERITON™ NM system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to obtain additional images, imaging planes, analysis results and uptake quantitation. The system may be used for patients of all ages.

The D-SPECT® Cardiac Scanner is an emission computed tomography system intended for detection of radioisotope tracer uptake in the patient's body and produce cross-sectional images through computer reconstruction of the data. The system uses a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated and Dynamic) and tomographic mode (Static, Multi-gated and Dynamic). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include gating by physiological signals, real-time body movement control, and low count rate (low dose) acquisition without loss of image quality. The D-SPECT® Cardiac Scanner may consist and display equipment contain data and image processing software to produce images in a variety of trans-axial and reformatted planes. To perform analysis and uptake quantitation and to apply the appropriate filters. The system utilizes combined images for attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration and fusion). The D-SPECT® Cardiac Scanner is intended for use by the appropriately trained healthcare professionals to aid in detecting, localizing and diagnosing of (but not limited) cardiac or individual organs diseases. The system output can be used for planning, guiding, and monitoring therapy.

Spectrum Dynamics D-SPECT® Cardiac Scanner System is a single photon emission computing tomography system intended for detection of radioisotope tracer uptake in the body and produce cross-sectional images through computer reconstruction of the data. The device uses a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. System's scanning modes include planar mode (Static, Multi-Gated and Dynamic) and tomographic mode (Static, Multi-Gated and Dynamic). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include gating by physiological signals, real-time body movement control. The device may proceed a low count rate (low dose) acquisition without loss of image quality. The device may utilize variate modalities to create attenuation corrected images along with functional and anatomical mapping imaging (localization, registration and fusion). The device is a high performance and compact Single Photon Emission Computed Tomography system intended for imaging of the breast and additional small organs in order to aid in the evaluation of lesions. The system detectors support radionuclides within the energy range of 40 -170 Kev. D-SPECT® Cardiac Scanner System comprising detector head, gantry, patient supports, uninterruptible power supply (UPS), image display and processing equipment, gating and real-time body movement control tools, interconnecting cables and related appurtenances. The device is available in two models, D-SPECT with nine detectors configuration and the D-SPECT L with six detectors configuration. D-SPECT® Cardiac Scanner System consist integrated signal analysis and display equipment or may use an FDA cleared D-SPECT® Processing and Reviewing Workstation (K160120) for image processing.