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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.

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.

3DXR is the AW application which is intended to perform the three-dimensional (3D) reconstruction computation of any images acquired with a 3D Acquisition mode of the X-ray interventional system for visualization under Volume Viewer. The 3D Acquisition modes are intended for imaging vessels, bones and soft tissues as well as other internal body structures. The 3D reconstructed Volume assist the physician in diagnosis, surgical planning, Interventional procedures and treatment follow-up.

3DXR is a post-processing software-only application, runs on Advantage Workstation (AW) platform [K110834], and performs 3D reconstruction for the CBCT 3D acquisition images (input) acquired from the fixed interventional X-ray system [K181403, K232344]. The reconstructed 3D volume (output) is visualized under Volume Viewer application [K041521]. The proposed 3DXR is a modification from the predicate 3DXR [included and cleared in K181403]. A new option, called CleaRecon DL, based on Deep-Learning (DL) technology, is added in the proposed subject 3DXR application.

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 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 of calcium in coronary arteries over time, and this information may aid the clinician in their determination of the prognosis of cardiac disease.

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 measurement's 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 the capability to automatically segment and label the calcifications within the coronary arteries, and then automatically compute a total and per territory calcium score. The calcium segmentation/labeling is using a new deep learning algorithm. The calcium scoring is based on the standard Agatston/Janowitz 130 (AJ 130) and Volume scoring methods for the segmented calcific regions. The software also provides the users a manual calcium scoring capability that allows them to edit (add/delete or update) auto scored lesions. It also allows the user to manually score calcific lesions within coronary arteries, aorta, aortic valve and mitral valve as well as other general cardiac structures. Calcium scoring offers quantitative results in the AJ 130 score, Volume and Adaptive Volume scoring methods. Calcium Scoring results can be exported as DICOM SR 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. Distance measurement and ROI tools are available for quantitative evaluation of the anatomy.

BreView is a tool to aid clinicians with the review of multi-parametric breast magnetic resonance (MR) images. The combination of acquired images, reconstructed images, annotations, and measurements performed by the clinician are intended to provide the referring physician with clinically relevant information that may aid in diagnosis and treatment planning.

BreView is a dedicated advanced visualization review and post-processing tool that facilitates optimized post-processing of MR breast data review and assessment workflows for radiologists - including organizing images and composing reports. Adding the techniques of automatic motion correction and subtraction improves the review process. Software functionalities include: - Ability to load 2D, 3D and 4D MR datasets as well as DICOM Secondary Captures (SCPT) . - Optimized display of multi-parametric images within a dedicated layout - Display customization: ability to choose layout, orientation, rendering mode - Guided workflows for reviewing and processing MR breast exams - Automated motion correction and/or subtraction of multi-phase datasets - . Multi-planar reformats and maximum intensity projections (MIPs) - Semi-automated segmentation and measurement tools - Graph view for multi-phase datasets - Save and export capabilities though DICOM Secondary Captures - Data export in the form of a summary table

The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and nonvascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures. The intended use and indications for use are unchanged from the predicate device.

GE HealthCare IGS interventional x-ray systems are designed to perform monoplane fluoroscopic x-ray examinations to provide the imaging information needed to perform minimally invasive interventional X-Ray imaging procedures (standard configuration). Additionally, in the OR configuration (with an OR Table), these systems allow to perform surgery and X-Ray image guided surgical procedures in a hybrid Operating Room. Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR are monoplane GE HealthCare IGS interventional X-Ray system product models. Each product model is designed with a set of components that are combined into different configurations for providing specialized interventional x-ray systems. GE HealthCare IGS interventional x-ray system consists of a C-arm positioner, an x-ray table or the interface to the radiologic table, an x-ray tube assembly, an x-ray power unit with its exposure control unit, an x-ray imaging chain (including a digital detector and an image processing unit). Allia IGS 5 is a monoplane system (C-arm positioner with L-shaped gantry) and is proposed in IGS 530 configuration with a square digital detector of 31cm (also called 30 cm configuration) or in IGS 520 configuration with a square digital detector of 20.5cm (also called 20 cm configuration). These product configurations are available in Standard configuration with Omega V table or Omega IV table (IGS 520 configuration only); or in OR configuration with Innova-IQ GE HealthCare OR table. Allia IGS 3 is a monoplane system (C-arm positioner with L-shaped gantry) and is proposed with a square digital detector of 31cm. This product is available in Standard configuration with Omega V table. Allia IGS 7 is a monoplane system (C-arm with mobile AGV gantry) and is proposed in IGS 730 configuration with a square 31cm digital detector (also called 30 cm configuration). This product configuration is described in sub configurations: Standard or OR configuration. The Innova-IQ table in the OR configuration is the GE HealthCare OR table. Allia IGS 7 OR is a monoplane system (C-arm positioner with mobile AGV gantry) and is proposed in IGS 730 OR configuration with a square 31cm digital detector configuration. This is the product model compatible with a qualified configuration of the Maquet Magnus OR table system. This product model is provided with a table integration kit. The Magnus OR table configuration compatible with Allia IGS 7 OR includes flat table top configurations for Interventional X-Ray imaging and surgery procedures, an optional universal table top (table top with articulated joints) to enable expansion to surgical procedures requiring advanced patient positioning and with X-Ray imaging capabilities. A set of Magnus OR table accessories is included in the compatible configuration. The purpose of this Premarket Notification is for the re-design of the x-ray source assembly. Allia IGS 3, Allia IGS 5 in IGS 520 and IGS 530 configurations, Allia IGS 7 in IGS 730 configuration, and Allia IGS 7 OR in IGS 730 OR configuration will be improved and will be marketed as Allia IGS 3 Pulse, Allia IGS 5 Pulse, Allia IGS 7 Pulse, and Allia IGS 7 OR Pulse. All these four models may also be designated with the marketing name Allia IGS Pulse.

Spine Auto Views is a non-invasive image analysis software package which may be used in conjunction with CT images to aid in the automatic generation of anatomically focused multi-planar reformats and automatically export results to predetermined DICOM destinations. Spine Auto Views assists clinicians by providing anatomically focused reformats of the spine, with the ability to apply anatomical labels of the vertebral bodies and intervertebral disc spaces. Spine Auto Views may be used for multiple care areas and is not specific to any disease state. It can be utilized for the review of various types of exams including trauma, oncology, and routine body.

Spine Auto Views is a software analysis package designed to generate batch reformats and apply labels to the spine. It is intended to streamline the process of generating clinically relevant batch reformat outputs that are requested for many CT exam types. Spine Auto Views can generate, automatically, patient specific, anatomically focused spine reformats. Spine Auto Views brings a state-of-the-art deep learning algorithm that generates oblique axial reformats, appropriately angled through each disc space without the need for a user interface and human interaction. 3D curved coronal and curved sagittal views of the spine as well as traditional reformat planes can all be generated with Spine Auto Views, no manual interaction required. Vertebral bodies and disc spaces can be labeled, and all series networked to desired DICOM destination(s), ready to read. The automated reformats may help in providing a consistent output of anatomically orientated images, labeled, and presented to the interpreting physician ready to read.

FlightPlan for Embolization is a post processing software package that helps the analysis of 3D X-ray angiography images. Its output is intended to be used by physicians as an adjunct means to help visualize vasculature during the planning phase of embolization procedures. FlightPlan for Embolization is not intended to be used during therapy delivery. The output includes segmented vasculature, and selective display of proximal vessels from a reference point determined by the user. User-defined data from the 3D X-ray angiography images may be exported for use during the guidance phase of the procedure. The injection points should be confirmed independently of FlightPlan for Embolization prior to therapy delivery.

FlightPlan for Embolization is a post-processing, software-only application using 3D X-ray angiography images (CBCT) as input. It helps clinicians visualize vasculature to aid in the planning of endovascular embolization procedures throughout the body. A new option, called AI Segmentation, was developed from the modifications to the predicate device, GE HealthCare's FlightPlan for Embolization [K193261]. It includes two new algorithms. This Al Segmentation option is what triggered this 510(k) submission. The software process 3D X-ray angiography images (CBCT) acquired from GE HealthCare's interventional X-ray system [K181403], operates on GEHC's Advantage Workstation (AW) [K110834] platform and AW Server (AWS) [K081985] platform, and is an extension to the GE HealthCare's Volume Viewer application [K041521]. FlightPlan for Embolization is intended to be used during the planning phase of embolization procedures. The primary features/functions of the proposed software are: - Semi-automatic segmentation of vasculature from a starting point determined by the user, when AI Segmentation option is not activated; - Automatic segmentation of vasculature powered by a deep-learning algorithm, when Al Segmentation option is activated; - Automatic definition of the root point powered by a deep-learning algorithm, when AI Segmentation option is activated; - Selective display (Live Tracking) of proximal vessels from a point determined by the user's cursor; - Ability to segment part of the selected vasculature; - Ability to mark points of interest (POI) to store cursor position(s); - Save results and optionally export them to other applications such as GEHC's Vision Applications ● [K092639] for 3D road-mapping.

DynamicIQ enables visualization and quantification of PET tracer pharmacokinetics based on whole body dynamic PET images. PET tracer pharmacokinetics include the physiological parameters of tracer uptake rate of the tracer and total blood distribution volume (Vd) that allow for analyzing the tracer accumulation over time, providing additional information that may help in the evaluation of SUV measurements on PET static images. The output of DynamicIQ is intended to be used by appropriately trained healthcare professionals as adjunct information for the review, analysis, and communication of PET static images for diagnosis, staging, treatment planning and monitoring. The parametric images should always be considered in addition to the conventional static PET images, which are the primary source to assist with diagnosis.

DynamiclQ is a post processing and visualization for visualizing and quantifying dynamic and static PET DICOM series. The software provides FDG tracer pharmacokinetics by generation of parametric images based on dynamic PET scans. The parametric images include physiological parameters of tracer uptake rate (Ki), metabolic rate of FDG and total blood distribution volume (Vd). In addition to the FDG Tracer pharmacokinetics, the software also performs the conventional review, analysis and communication of conventional PET static images, CT and MR images. DynamicIQ assists with the clinical workflow by providing adjunct information of FDG tracer pharmacokinetics along with conventional PET static images for cross reference. The adjunct information of FDG tracer pharmacokinetics also help with analyzing the images that could have variability of quantitative measurements due to differences in uptake time, patient body size and blood glucose levels, leading to better characterization of tracer uptake compared to SUV alone.

Vision 2, EVARVision, TrackVision 2 and HeartVision 2 software applications are intended to enable users to load 3D datasets and overlay and register in real time these 3D datasets with radioscopic or radiographic images of the same anatomy in order to support catheter/device guidance during interventional procedures. Structures of interest and estimated dimensions can be overlaid on the radioscopic or radiographic images. Image processing can be applied to enhance the display of such images. This information is intended to assist the physician during interventional procedures. The Stereo 3D option enables physicians to visualize and localize needles, points, and segments on a 3D model/space using a stereotactic reconstruction of radioscopic or radiographic images at a significantly lower dose than use of a full cone beam CT acquisition. This information is intended to assist the physician during interventional procedures.

Vision Applications are a group of software applications called Vision 2, EVARVision, TrackVision 2 and HeartVision 2 that share the same core functionalities to target different clinical procedures. Vision Applications load 3D datasets previously acquired from an acquisition modality (CT, MR or CBCT) and prepared with Volume Viewer application [K041521]. They overlay and register in real-time these 3D datasets with the 2D X-ray live images acquired from the GE Interventional X-ray system [K181403] (called IGS X-ray system in the rest of the document) to help support localization and guidance of catheters / devices during interventional procedures, in conjunction with primary images, native live 2D X-ray images. Vision Applications help physicians to perform interventional procedures by providing enhanced image quality and additional 3D information instead of 2D X-ray live images alone. Vision Applications operate on GE's Advantage Workstation (AW) [K110834] platform and communicates with the IGS X-ray system [K181403] for receiving the live X-ray images. The subject device, Vision Applications were developed from modifications to the primary predicate device Innova Vision Applications [K092639], including the addition of new optional feature "Digital Pen". The Digital Pen option is what triggered this 510k and was modified from the reference device, GE's IGS X-ray systems [K181403] under the name Stenosis Analysis. The Vision Applications include also Stereo 3D option feature [K152352, secondary predicate]. The primary features/functionalities of the Vision Applications are: - . Digital Pen. - Overlay of 2D/3D images. - Reception and display of live 2D images and related information. ● - Loading of 3D datasets. - Review mode. - Film/Sequence/photo store. - . Display controls for Visualization of images: including Zoom/Roam, Rendering, Planning data display, Annotation display, Virtual Collimation, ECG Display, Calcification Visualization Enhancement, display adjustment tools. - Automatic Registration: including A priori registration and Registration based on Augmented Calibration. - Manual Registration. - Bi-view registration. - User Interface: control from AW and from Tableside. - . 2D Modes. - Send Angles: including EVAR Angles, Progress View/Bull's eye. - . Stereo 3D.