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The NeuViz 128 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

The proposed NeuViz 128 Multi-slice CT Scanner System is composed of a gantry, a patient couch, an operator console and includes image acquisition hardware and software, and associated accessories. It is designed to be a head and whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.

The NeuViz 16 Essence Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

The NeuViz 16 Essence Multi-Slice CT Scanner System is composed of a gantry, a patient couch, an operator console and includes image acquisition hardware and software, and associated accessories. It is designed to be a head and whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system provides the filter back-projection (FBP) and iterative reconstruction algorithm(ClearView cleared in K133373) to reconstruct images. The end user can choose to apply either ClearView or the FBP to the acquired raw data. The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation. It provides the following digital image processing and visualization tools: - Support following scan speed: 0.5s、0.6s、0.75s、1.0s、1.5s、2.0s. - · Surview scan - Dual surview - · Spiral scan - Axial scan - Image reconstruction - Plan scan - Patient information management - Patient information registration - Protocol selection - O-Dose - . Bolus tracking - SAS - Home - Film - Report - 2D - MPR - 3D - VE(Virtual Endoscopy) - Vessel Analysis - Dicom Viewer - · Bar code Reader - Dual Monitor - Continuous CT - ClearView - Dental Analysis - Virtual Colonoscopy - Brain Perfusion - Body Perfusion - Lung Nodule Analysis

The NeuViz Prime Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

The NeuViz Prime Multi-Slice CT Scanner System is composed of a gantry, a patient couch, an operator console and includes image acquisition hardware and software, and associated accessories. It is designed to be a head and whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system provides the filter back-projection (FBP) and iterative reconstruction algorithm(ClearView cleared in K133373) to reconstruct images. The end user can choose to apply either ClearView or the FBP to the acquired raw data. The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation. It provides the following digital image processing and visualization tools: - · Support following scan speed: 0.259s(option), 0.32s(option), 0.374s(option), 0.4s(option), 0.5s, 0.6s, 0.8s, 1.0s, 1.5s, 2.0s. - . Surview scan - Dual surview - Spiral scan - Axial scan - Image reconstruction - Plan scan - Patient information management - Patient information registration - Protocol selection - O-Dose - · Bolus tracking - SAS - Home - Film - Report - 2D - MPR - 3D - VE(Virtual Endoscopy) - Vessel Analysis - Dicom Viewer - Bar code Reader - Dual Monitor - CCT Scan - ClearView - iHD - Cardiac Scan - Dual Energy Scan and Reconstruction ● - Dental Analysis - Virtual Colonoscopy - Brain Perfusion - Body Perfusion - · Lung Nodule Analysis - Lung Density Analysis - · Coronary Analysis - Cardiac Calcium Scoring . - Cardiac Function Analysis - Cardiac Viewer - Fat Analysis - CTDSA - Tumor Assessment - · Preprocessing function - AVW.Cloud - · Prism Viewer

The NeuViz 128 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

The NeuViz 128 Multi-slice CT Scanner System is composed of a gantry, a patient couch, an operator console and includes image acquisition hardware and software, and associated accessories. It is designed to be a head and whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system provides the filter back-projection (FBP) and iterative reconstruction algorithm(ClearView cleared in K133373) to reconstruct images. The end user can choose to apply either ClearView or the FBP to the acquired raw data. The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation. It provides the following digital image processing and visualization tools: - Support following scan speed:0.374s、0.5s、0.6s、0.8s、1.0s、1.5s、2.0s. - · Surview scan - · Dual surview - o Spiral scan - o Axial scan - Image reconstruction - Plan scan - Patient information management - Patient information reqistration - O Protocol selection - Bolus Tracking - CCT scan - . Cardiac scan - Multi-phase scan - O Tube Warm-up - Film - Report - O 2D - DICOM Viewer O - O MPR - 0 3D - Virtual Endoscopy - . Dental - Vessel Analysis - Virtual Colonoscopy - Brain Perfusion - · Body Perfusion - Lung Nodule Analysis - Lung Density Analysis - Coronary Analysis - Cardiac Calcium Scoring - Cardiac Function Analysis - Cardiac Viewer - Fat Analysis - CTDSA - Tumor Assessment

The NeuSight PET/CT Scanner System can be used for the functional and anatomical imaging of human bodies and organs. The device is intended for whole body or regional tumor examination, cardiac examination and head examination. The device can assist in radiotherapy planning and be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system. Trained doctors can read useful diagnostic information from the image generated.

The NeuSight PET/CT Scanner System is an integrated multi-slice Computed Tomography and Positron Emission Tomography scanner. It uses CT images to correct for non-uniform attenuation of the PET images and it uses integrated CT and PET images to localize emission activity in the patient anatomy. NeuSight System has capabilities for imaging all available PET tracers and CT contrast agents and can provide inherently registered anatomical and functional information via an integrated graphical user interface. The product provide some reconstruct methods, such as FBP、3DRP、OSEM、 ClearView (cleared in K133373) , and some advance algorithms based on OSEM. These advance algorithms can improve the image quality. The NeuSight PET/CT Scanner System consists of two variants: - NeuSight PET/CT 64 - NeuSight PET/CT 16 NeuSight PET/CT 16 is designed based on NeuSight PET/CT 64 and has the same hardware configuration with NeuSight PET/CT 64. Their hardware of CT part is the same as NeuViz64 (K121792). In the performance parameters, NeuSight PET/CT 16 only limits the optional scope of partial scan parameters by software in order to different from NeuSight PET/CT 64. There's no essential technological difference between the two types of PET/CT and the safety and effectiveness of these products could be ensured through verification, validation and difference assessment.

ClearView is a CT reconstruction software. The end user can choose to apply either ClearView or the filter back-projection (FBP) to the acquired raw data. Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ClearView can help to reduce radiation dose while maintaining Pixel noise, low contrast detectability and high contrast resolution. Phantom measurements showed that high contrast resolution and pixel noise are equivalent between full dose FBP images and reduced dose ClearView images. Additionally, ClearView can reduce body streak artifacts by using iterations between image space and raw data space. A Model Observer evaluation showed that equivalent low contrast detectability can be achieved with less dose using ClearView at highest noise reduction level for thin (0.625 mm) reconstruction slices in MITA body and ACR head phantoms for low contrast objects with different contrasts. ClearView are not intended to be used in CCT and Pilot.

ClearView reconstruction technology may enable reduction in pixel noise standard deviation and improvement in low contrast resolution. ClearView reconstruction algorithm may allow for reduced mAs in the acquisition of image, thereby it can reduce the dose required. In clinical practice, the use of ClearView reconstruction may reduce CT patient dose depending on the clinical task, patient size, and clinical practice. A consultation with a radiologist and physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task. As a reconstruction option, ClearView can be selected before scanning or after scanning. There are 9 ClearView Levels from 10% to 90%. Users can select t.the level of ClearView that is appropriate for the clinical task being performed. According to the comparison based on the requirements of 21 CFR 807.87, we stated that ClearView reconstruction software is substantially equivalent to the FBP of NeuViz 64 Multi-Slice CT Scanner System. ClearView is a moderate concern device.

The NeuViz 64 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

The NeuViz 64 Multi-slice CT Scanner System is composed of a gantry, a patient couch, an operator console and includes image acquisition hardware and software, and associated accessories. It is designed to be a head and whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation.

The NeuColonCARE is a soft-copy reading workstation intended for clinical review of CT abdominal (gastrointestinal) images which allows easy acquisition, transmission and review of the medical images and supports VC (Virtual Colonoscopy) function. Images may be interpreted by a trained physician to obtain information that may be useful in the determination of a diagnosis.

NeuColonCARE software product is a soft-copy reading workstation used to clinically evaluate the CT abdominal (gastrointestinal) images. It is a self-contained software package, providing the functions of patient information management, image viewer (2D view, standard MPR views and 3D visualization view), and the analysis and processing of the gastrointestinal system, especially the colon. It allows the user to conduct air segmentation based on a customized threshold value, extract the centerline automatically and interactively, view the colon lumen structure in the manner of virtual colonoscopy or virtual dissection along the centerline, view the ROI, and finally acquire useful clinical information by marking and measuring the ROI (3D distance and CT value).

BeyondImage Workstation is a software application that is used for viewing medical images. Beyond mage Workstation receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and digital radiographic devices). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Taking that users may perform when viewing images include, but are not limited to adjustment of window width and center; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images, it also provides standard Multi-Planar Reconstruction (MPR) views, Curved-Planar Reconstruction (CPR) views and 3D views of Volume Rendering for digital images from CT, MR, and PET unit. In addition, using Beyondlmage Workstation, users can edit and print report. Beyondlmage Workstation cannot display and process mammograms. Typical users of Beyondlmage Workstation are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

BeyondImage Workstation is a software application that provides image viewing and manipulation in a diagnostic imaging setting. The functions of this application are applied to medical images that are acquired and stored on an image server in DICOM format. Beyondlmage Workstation can also transfer images in DICOM 3.0 format over a medical imaging network, as well as exporting images to applications in other proprietary formats.

The NeuViz 16 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multislice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional imagers of the body from the same axial plane taken at different angles. The system is suitable for all patients.

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