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Hybrid Viewer is a software application for nuclear medicine and radiology. Based on user input, Hybrid Viewer processes, displays and analyzes nuclear medicine and radiology imaging data and presents the result to the user. The result can be stored for future analysis. Hybrid Viewer is equipped with dedicated workflows which have predefined settings and layouts optimized for specific nuclear medicine investigations, The software application can be configured based on user needs. The investigation of physiological or pathological states using measurement and analysis functionality provided by Hybrid Viewer is not intended to replace visual assessment. The information obtained from viewing and/or performing quantitative analysis on the images is used, in conjunction with other patient related data, to inform clinical management,

Hybrid Viewer provides general tools for viewing and processing nuclear medicine and radiology images. It includes software fornuclear medicine (NM) processing studies for specific darts of the body and specific diseases using predefined workflows. Hybrid Viewer 7.0 includes the following additional clinical features compared to Hybrid Viewer 2.8: • Additional DICOM file support for Segmentation (SEG), RT Dose and CT Fluoroscopy · Three energy window (TEW) correction for whole body studies • Automatic motion correction and additional motion correction option for dual isotope • Display quantitative SPECT studies in SUV units • Additional NM processing workflows for: - Assessment of the percentage of activity which is shunted to the lung prior to Y90 microsphere treatment planning. - Assessment of the ratio of activity in the heart compared to the mediastinum. The workflow contains specific options for the GE Healthcare product AdreView™, a radiopharmaceutical agent used in the detection of primary or secondary pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests. - Assessment of the relative uptake in right, left and duplex kidneys in DMSA™ (dimercaptosuccinic acid) SPECT studies. This is an extension of an existing workflow for planar DMSA studies.

AFFINITY is a software application used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstations, PACS or acquisition stations. The information acquired from viewing the images is used, in conjunction with other patient related data, for diagnosis and monitoring of disease. Warning! This application is not intended to replace visual assessment of tumors. The application is to provide pre-selection of lesions for visual confirmation and to provide consistency and reproducibility when assessing tumor response to treatment

Affinity is a software application used to process, display, analyse and manage nuclear medicine and other medical imaging data transferred from other workstations, PACS or acquisition stations. The information acquired from viewing the images is used, in conjunction with other patient related data, for diagnosis and monitoring of disease. This application is not intended to replace visual assessment of tumors. The primary purpose of the application is to provide pre-selection of lesions for visual confirmation and to provide consistency and reproducibility when assessing tumor response to treatment. Affinity can process data as whole body or constrained field of view (e.g. abdomen, brain) where scanning was performed with any of the following modalities PET/CT, MR or tomographic reconstructed SPECT/CT. The studies are read in DICOM format and if there are studies with different modalities, on the same patient, a co-registration and alignment is performed. Software output - After the studies have been processed, these are presented visually in 2D or 3D for the user who can use tools to quantify the significant parameters SUV, SUVR, SUVbsa, SUVIbm, SUVbw, SUV Peak, SUV Mean, TLG and MTV.

AFFINITY is a software application used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstations, PACS or acquisition stations. The information acquired from viewing the images is used, in conjunction with other patient related data, for diagnosis and monitoring of disease.

The Affinity v1.0 is a Viewer that will be the first Hermes application released on the new development platform Affinity. The application provides 2D and 3D visualization and processing of medical images in Digital Imaging and Communications in Medicine (DICOM) format from different modalities, such as PET/CT, MR and tomographic reconstructed SPECT from SPECT/CT. Affinity supports coregistration, with the exception of 2D images, and fusion of multiple time points with studies in the same frame of reference, different tracers, and modalities. Affinity is developed with Microsoft Visual Studio on the .NET framework environment and designed for high throughput clinical scenarios with fast image loading and configurable workflows and layouts. In the design, emphasis has been placed on ease of use, where the user can easily access tools for 3D ROI and uptake analysis. The application supports pre-selection and automatic detection of all uptake areas within the body above a certain threshold level, by using threshold region tool. Where the user can define a threshold for any modality and unit within that modality to include all pixels of the study in a region or islands of regions. Based on selected regions, quantification of the following parameters can be done SUV, SUVR, SUVbsa, SUVlbm, SUVbw, SUV Peak, SUV Mean, TLG and MTV.

The intended use of Voxel Dosimetry™ is to provide estimates (deterministic) of absorbed radiation dose at voxel as a result of administering one of the supported radionuclides and to provide a dose map. This is dependent on input data regarding bio distribution being supplied to the application. Voxel Dosimetry™ only allows voxel-based dose calculations for patients who have been administered with radioisotopes. Warning! The Voxel Dosimetry™ is only intended for calculating dose for FDA approved radiopharmaceuticals for any clinical purpose, and calculation of unapproved drugs can only be used for research purpose.

Voxel Dosimetry™ is a tool for voxel level absorbed dose calculation resulting from radiotracer injection. Voxel Dosimetry™ workflow consists of the following steps: - SPECT/CT or PET/CT DICOM data loading from the data manager GOLD or PACS - Registration of different time-points to a common reference study - Generation and integration of voxel-level time-activity curves - Voxel-level absorbed dose calculation using a Monte Carlo-method - Saving of the absorbed dose-map back to GOLD or PACS in DICOM format

Hybrid3D that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

HERMES Hybrid3D is a reading and processing module for the advanced needs in medical imaging. It offers multi-modal (PET/CT/MR/SPECT) coregistration and interactive fusion of multiple datasets. HybridViewer 3D handles viewing and fusion of multi-sequence MRI studies with oblique orientation and allows switching between original and standard TCS view orientation as well as defining own slice directions. 3D seqmentation, cropping and interpolation techniques allow complex tasks in VOI definition and can cover cases like cavities, splitting structures into subsections or logic operations (compute intersections, merge, grow). Results can be imported and exported as DICOM and are therefore available for research in 3rd party tools. Additionally, it provides tools for advanced 3D fusion rendering of studies and VOIs. Lung Lobe Quantification: The Lung Lobe Quantification module in Hybrid3D, introduces an efficient and automated workflow solution to accurately compute 3D lobar anatomy from CT (with or without contrast). The workflow supports the addition of functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) to accurately relate lobar anatomy to function. No changes have been made to Lung Lobar Quantification since the previous release. TumorFinder: The Tumor Finder wizard provides automatic segmentation of lesions in a PET study or a combined PET/CT study pair, based on criteria relative to a background volume placed in the liver or mediastinum. This reduces the time required for tumor delineation. It also provides both visual and statistical evaluation of tumor burden, which helps with comparing follow up studies. SIRT: Selective Internal Radionuclide Therapy (SIRT), is currently used in the treatment of liver tumors either from primary liver cancer or metastatic disease (e.g. colorectal primary cancer). The SIRT wizard provides processing for SIRT planning and verification.

HERMES Medical Imaging suite that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

The base product design of Hermes Medical Imaging Suite v5.7 is the same as for the Hermes Medical Imaging Suite v5.6 (K153056). The following modules have been added in this applicatio to Hybrid Viewer NM Processing: Colonic Transit, Remnant Liver, Parathyroid, Dosimetry, Classic DMSA, Oesophageal Transit/Reflux, HIDA, Salivary Gland, Bone3Phase Analysis and Uniformity.

Hybrid3D that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

HERMES Hybrid3D is a reading and processing module for the advanced needs in medical imaging. It offers multi-modal (PET/CT/MR/SPECT) coregistration and interactive fusion of multiple datasets. HybridViewer 3D handles viewing and fusion of multi-sequence MRI studies with oblique orientation and allows switching between original and standard TCS view orientation as well as defining own slice directions. 3D segmentation, cropping and interpolation techniques allow complex tasks in VOI definition and can cover cases like cavities, splitting structures into subsections or logic operations (compute intersections, merge, grow). Results can be imported and exported as DICOM and are therefore available for research in 3rd party tools. Additionally, it provides tools for advanced 3D fusion rendering of studies and VOIs. The Lung Lobe Quantification module in Hybrid 3D, introduces an efficient and automated workflow solution to accurately compute 3D lobar anatomy from CT (with or without contrast). The workflow supports the addition of functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) to accurately relate lobar anatomy to function.

The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application.

The OLINDA/EXM® v2.0 is a modification of OLINDA/EXM® v1.1 (K033960) and includes new human models and nuclides. OLINDA/EXM® 2.0 employs a new set of decay data recommended by the International Commission on Radiological Protection (ICRP). OLINDA/EXM® 2.0 introduces a new series of anthropomorphic human body models (phantoms), so new values of Specific Absorbed Fractions (SAF), di (T←S) were generated. These phantoms were based on updated values of the mass of the target region (mr) recommended by the ICRP. The base product design of OLINDA/EXM® V2.0 is the same as for the OLINDA/EXM® V1.1 (K033960).

Hybrid3D that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

The Lung Lobe Quantification module in Hybrid 3D, introduces an efficient and automated workflow solution to accurately compute 3D lobar anatomy from CT (with or without contrast). The workflow supports the addition of functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) to accurately relate lobar anatomy to function.