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The Philips iCT CT systems is a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. The iCT is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society. *Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

The Philips iCT CT System is a whole-body computed tomography (CT) X-ray system designed for diagnostic imaging. It features a continuously rotating X-ray tube and multi-slice detector gantry, enabling the acquisition of X-ray transmission data from multiple angles and planes. The system reconstructs these data into cross-sectional images using advanced image reconstruction algorithms, supporting a wide range of clinical applications. The system consists of a gantry, which houses the rotating X-ray tube, detector array, and key imaging subsystems; a patient support couch, which moves the patient through the gantry bore in synchronization with the scan and is available in multiple configurations; an operator console, which serves as the primary user interface for system controls, image processing, and data management; and a Data Measurement System (DMS), which captures X-ray attenuation data to support high-quality image reconstruction.

Hasla is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.

The product (Dental CBCT X-ray System, Model: Hasla) uses cone-beam computed tomography (CBCT) through X-ray cone-beam, panoramic radiography, cephalometric radiography to produce images of the dental, oral and maxillofacial areas to provides diagnostic details for the medical facilities. This product consists of Frame, X-ray generator (including Integrated X-ray source tube head, X-ray tube, Collimator), Image receptor and Image processing system (including Computer, Monitor, and Software workstation).

This device is indicated to acquire and display cross-sectional volumes of the whole body (abdomen, pelvis, chest, extremities, and head) of adult patients. TSX-501R has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

CT Scanner TSX-501R/1 V11.1 employs a next-generation X-ray detector unit (photon counting detector unit), which allows images to be obtained based on X-rays with different energy levels. This device captures cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems.

CardIQ Suite is a non-invasive software application designed to provide an optimized application to analyze cardiovascular anatomy and pathology based on 2D or 3D CT cardiac non contrast and angiography DICOM data from acquisitions of the heart. It provides capabilities for the visualization and measurement of vessels and visualization of chamber mobility. CardIQ Suite also aids in diagnosis and determination of treatment paths for cardiovascular diseases to include, coronary artery disease, functional parameters of the heart, heart structures and follow-up for stent placement, bypasses and plaque imaging. CardIQ Suite provides calcium scoring, a non-invasive software application, that can be used with non-contrasted cardiac images to evaluate calcified plaques in the coronary arteries, heart valves and great vessels such as the aorta. The clinician can use the information provided by calcium scoring to monitor the progression/regression of calcium in coronary arteries overtime, and this information may aid the clinician in their determination of the prognosis of cardiac disease. CardIQ Suite also provides an estimate of the volume of heart fat for informational use.

CardIQ Suite is a non-invasive software application designed to work with DICOM CT data acquisitions of the heart. It is a collection of tools that provide capabilities for generating measurements both automatically and manually, displaying images and associated measurements in an easy-to-read format and tools for exporting images and measurements in a variety of formats. CardIQ Suite provides an integrated workflow to seamlessly review calcium scoring and coronary CT angiography (CCTA) data. Calcium Scoring has a fully automatic capability which will detect calcifications within the coronary arteries, label the coronary arteries according to regional territories and generate a total and per territory calcium score based on the AJ 130 and Volume scoring methods. Interactive tools allow editing of both the auto scored coronary lesions and other calcified lesions such as aortic valve, mitral valve as well as other general cardiac structures. Calcium scoring results can be compared with two percentile guide databases to better understand a patient's percentage of risk based on age, gender, and ethnicity. Additionally, for these non-contrasted exams, the heart fat estimation automatically estimates values within the heart that constitute adipose tissue, typically between –200 and –30 Hounsfield Units. Calcium Scoring results can be exported as DICOM SR, batch axial SCPT, or a PDF report to assist with integration into structured reporting templates. Images can be saved and exported for sharing with referring physicians, incorporating into reports and archiving as part of the CT examination. The Multi-Planar Reformat (MPR) Cardiac Review and Coronary Review steps provide an interactive toolset for review of cardiac exams. Coronary CTA datasets can be reviewed utilizing the double oblique angles to visually track the path of the coronary arteries as well as to view the common cardiac chamber orientations. Cine capability for multi-phase data may be useful for visualization of cardiac structures in motion such as chambers, valves and arteries, automatic tracking and labeling will allow a comprehensive analysis of the coronaries. Vessel lumen diameter is calculated, and the minimum lumen diameter computed is shown in color along the lumen profile. Distance measurement and ROI tools are available for quantitative evaluation of the anatomy. Vascular findings of interest can be identified and annotated by the user, and measurements can be calculated for centerline distances, cross-sectional diameter and area, and lumen minimum diameter.

The Aurora system is a medical tool intended for use by appropriately trained healthcare professionals to aid detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; and planning, guiding, and monitoring therapy, including the nuclear medicine part of theragnostic procedures.

GEHC's Aurora is a SPECT-CT system that combines an all-purpose Nuclear Medicine imaging system and the commercially available Revolution Ascend system. It is intended for general purpose Nuclear Medicine imaging procedures as well as head, whole body, cardiac and vascular CT applications and CT-based corrections and anatomical localization of SPECT images. Aurora does not introduce any new Intended Use. Aurora consists of two back-to-back gantries (i.e. one for the NM sub-system and another for the CT subsystem), patient table, power distribution unit (PDU), operator console with a computer for both the NM acquisition and SmartConsole software and another for the CT software, interconnecting cables, and associated accessories (e.g. NM collimator carts, cardiac trigger monitor, head holder). The CT sub-system main components include the CT gantry, PDU, and CT operator console. All components are from the commercially available GEHC Revolution Ascend CT system.

The SCENARIA View system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The SCENARIA View system can also be used for interventional needle guidance. Volume datasets acquired by a SCENARIA View system can be post-processed in the SCENARIA View system to provide additional information. Post-processing capabilities of the SCENARIA View software include multi-planar reconstruction (MPR), and volume rendering. Volume datasets acquired by a SCENARIA View system can be transferred to external devices via a DICOM standard interface. The Low Dose CT Lung Cancer Screening Option for the SCENARIA View system is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or FUJIFILM Corporation. The SCENARIA View system is intended for general populations.

The subject device SCENARIA View is a multi-slice CT system consists of a gantry, operator's workstation, patient table, high-frequency X-ray generator, and accessories. The system performance is similar to the predicate device. The SCENARIA View system uses 128-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 64 slices of data simultaneously. The X-ray sub-system features a high frequency generator, X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles. The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system. Compared to the predicate device referenced within this submission, the subject devices support the following modifications: 1) New features - AutoPose is an AI-based function that recognizes a specific body part in an image of localization scan and then automatically sets the scan range and the image reconstruction range. - RemoteRecon is a function of setting image reconstruction parameters that runs on the external personal computer (hereinafter referred to as "PC") connected to the CT system. 2) Modified features - The maximum load capacity of patient table type has been increased from 250kg to 300 kg. - Motion corrected reconstruction is an image reconstruction feature that reduces motion artifacts. The feature has been modified to include applicability for chest examinations, which is a non-gated scan. - AutoPositioning is a feature that assist in positioning the patient by camera images. The feature has been modified to include additional 12 body parts (Head and Neck, Neck, C-spine, Heart, Chest-Abdomen, Chest-Upper Abdomen, Abdomen-Pelvis, Abdomen, Pelvis, T-spine, L-spine, T-L-spine), in addition to the 2 body parts (Head, Chest) of the predicate device, with scanogram ranges displayed according to the selected protocol.

uCT ATLAS Astound is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS Astound is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography. uCT ATLAS Astound is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society. *Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. uCT ATLAS is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography. uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc. uCT ATLAS is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society. *Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. uWS-CT-Dual Energy Analysis is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.

The uCT ATLAS Astound with uWS-CT Dual Energy Analysis and uCT ATLAS with uWS-CT Dual Energy Analysis includes the same intended use and same indications for use as their recent cleared versions (K231482). The reason for this submission is to support the following additional functions: - CardioXphase (optimized) - CardioBoost - CardioCapture (optimized) - AIIR - Motion Freeze - Ultra EFOV

The Spectral CT system is a Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment support, component parts, and accessories. The Spectral CT system acquires one CT dataset – composed of data from a higher-energy detected X-ray spectrum and a lower- energy detected X-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology and in oncology as part of treatment preparation and radiation therapy planning. The Extended field of view images and respiratory correlated scanning (4DCT) are for treatment preparation and radiation therapy planning/simulation usage only. This device is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The system is also intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society. *Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl. J Med 2011; 365:395-409) and subsequent literature, for further information.

Spectral CT system is a whole-body computed tomography (CT) X-ray system featuring a continuously rotating X-ray tube and detectors gantry, and multi slice capability. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This system also includes signals analysis and display equipment, patient and equipment support, components, and accessories. The Spectral CT system acquires one CT dataset – composed of data from a higher energy detected X-ray spectrum and a lower- energy detected X-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and provides information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number. The Spectral CT system consists of three main components – a scanner system that includes a rotating gantry, a movable patient couch, and an operator console for control and image reconstruction; a Spectral Reconstruction System; and a Spectral CT Viewer. On the gantry, the main active components are the X-ray high voltage (HV) power supply, the X-ray tube, and the detection system. The fundamental design and characteristics of the main components used in the proposed Spectral CT system are identical to the currently marketed primary predicate device, Spectral CT system (K203020).

VersaViewer is a medical diagnosis software supporting 2D, 3D and 4D medical images series for their processing and analysis through customizable layouts allowing multimodality review. It streamlines standard and advanced medical imaging analysis by providing a suite of measurements capabilities. It is designed for use by trained healthcare professionals and is intended to assist the physician in diagnosis, who is responsible for making all final patient management decisions. VersaViewer is not intended for the displaying of digital mammography images for diagnosis.

VersaViewer is a software application for processing and analysis of 2D, 3D and 4D medical imaging data. The application provides adaptive layout to display selected series and, common radiology toolset to perform measurements. It aims to enable the review of medical imaging acquisitions for which a dedicated advanced visualization application is not required. VersaViewer has the following functionalities: - Reconstruct and display 2D, 3D and 4D medical images from multiple modalities. - Display relevant series in an adaptive layout based on user selection. - Access and dynamically load series of interest through embedded Series Selector. - Allow to select different image rendering modes such as Volume Rendering, MIP (maximum intensity projection) /MinIP (minimum intensity projection) / Average, MPR (multiplanar reformation) and Oblique. - Basic image review tools including paging, WW/WL adjustment and zoom. 3D volumes can be visualized in adjustable multi-oblique planes. - Set of annotation, measurement, and segmentation tools. - Dedicated panel collects findings as they are deposited on the images and enables user to manage them. - Images and findings export options. VersaViewer also includes One View as an optional feature. One View provides reformatted views to assist radiologists in interpreting various types of spectral exams by projecting GSI (Gemstone Spectral Imaging) material decomposition images over monochromatic and color overlay.

The Dental Cone Beam Computed Tomography System is intended to be used by medical institutions for X-ray image diagnosis on oral and maxillofacial areas through X-ray Cone Beam Computed Tomography (CBCT).

The system consists of X-ray tube assemblies, collimators, flat panel detector, control devices (the touch screen, the control panel, the console panel and the exposure switch), auxiliary positioning devices(the lifting seat and the chin rest) and U-shape gantry (the X-ray tube assembly support, the base and the Detector Support), and workstation. The system is an open design that allows patients to sit upright during a procedure. An electric powered seat is built into the scanner for proper patient positioning. The system has 2 configurations: the Configuration 1 has two X-ray tube assemblies(X-ray tube assembly A and X-ray tube assembly B) and two collimators(A and B), the Configuration 2 only has X-ray tube assembly A and collimator A. The proposed device is a CBCT dental system utilizes X-ray to obtain cross-sectional images of patient's oral and maxillofacial areas. The image software can reconstruct data and clearly display the 3D anatomical structure of the oral and maxillofacial areas, and achieve the multi-slice at any level, accurate measurement, contour plots and so on in the workstation software, greatly facilitating the clinical application of stomatology. The Lifting Seat moves up and down via buttons on the system Control Panel allowing positioning and adjustment of patients at different heights; the Touch Screen facilitates the adjustment of projection parameters and the control of actions of the device; the Gating and the shielding door are the safety interlock of the X-ray beam exposure to prevent the dose leakage caused by abnormal operation; the Exposure Switch controls the exposure output of the whole machine in real time during the scanning process. There are four FOV sizes; 20cm x 18cm high resolution is for diagnostic imaging of maxillary region, mandibular region, TMJ region and other craniofacial region, and it is only available for configuration 1; 17cm x 10.5cm high resolution , 8cm x8cm Super Resolution and 4cm x4cm Super Resolution are for diagnostic imaging of maxillary region and mandibular region. Under High Resolution mode, patients will receive lower radiation dose compared to Super Resolution. Dose radiation for each mode is different for pediatric and adult patients.