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The Viatronix V3D-Cardiac is intended to be used for the display and 2D/3D visualization of medical image data derived from CT of the human heart. The goal of this non-invasive, image analysis software package is to assist physician in diagnosing of cardiovascular disease to include, coronary artery disease, functional problem of left ventricle, myocardium anomaly, other heart diseases, and follow-up for stent/graft placement, bypasses and plaque imaging. The image post-processing tools are applied real time on-line by the physician's interactive demand. There is no image processing stage required prior to the start of the using of the V3D-Cardiac. The Viatronix V3D-Cardiac provides a set of fully or semi-automated tools, including, rib cage removal, initial coronary vessel tree segmentation, selected vessel segmentation, vessel crosssectional size measurements, and left ventricle volume functional parameter computation. The V3D-Cardiac will also provide automated setting and display of conventional cardiac imaging planes based on a single user input: selection of the aorta valve. The automatic 2D/3D view correlation is available for vessel analysis views. User can virtually fly thru the vessel lumen in the endoluminal 3D view. Manual tools for adjusting location of center of mitral valve for left ventricle region segmentation are provided. The V3D-Cardiac is intended for use by radiologist, clinicians and referring physicians to acquire, process, render, measure, evaluate, archive, print and distribute DICOM 3.0 compliant coronary artery, left ventricle and other heart anatomy images, utilizing PC hardware.

The Viatronix V3D-Cardiac is a software device for evaluating scanned images of heart. It is designed to aid the physician in analyzing the heart anatomy and detecting anomaly based on images from a CT scan. The heart anatomy includes coronary arteries, cardiac chambers, aorta root, cardiac valve, myocardium, and other parts of the heart. The goal is to simplify the physician's work as much as possible by providing fully or semi-automated tools for segmenting and measuring coronary artery and left ventricle and displaying reformatted images for visualizing complicated heart anatomy. It is an additional image processing option specific to heart imaging procedure added to our V3D visualization system product line, which pre-market clearance was granted by the FDA vide K002780, K013146, K020658, K022789, K032483, K033361, and K040126. It is a general software module, designed for use as a part of our V3D visualization system core technology. The V3D visualization system consists of V3D processor and V3D viewer in multiple computer configuration or V3D processor and V3D viewer in a stand alone one computer configuration. Upon receipt of contrast enhanced, multi-slice CT scan images of human heart in a DICOM format, the V3D processor converts the DICOM image data into an internally recognized volume data format using our core software technology. If there are more than one phase images available, the V3D-processor shall automatically extract each phase image into a separate volume and label the phase percentage information based on the header information from DICOM images. The V3D-Cardiac is an organ specific V3D viewer application. The V3D-Cardiac provides interactive orthogonal and multi-planar reformatted 2D and 3D images. User can evaluate those images for normality or malformation in specified part of heart obtained from scanned CT images.

The Viatronix V3D Colon is a system for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT and MR scans, for the purpose of patient screening for detection of colon cancers, polyps, masses, and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon from rectum to cecum and vice versa for both prone and supine views. It generates a centerline for guided interactive navigation and fly through of the entire colon, and also includes a reporting facility to enhance workflow for patient screening. It is intended for use by Radiologists, Clinicians and referring Physicians to process, render, review, archive print and distribute colon image studies utilizing PC hardware.

The Viatronix V3D Colon contains all of the required hardware and software components to provide interactive 3D and 2D views of diagnostic CT and MR scan images of the colon. The views include both inner and outer surface 3D volume rendered images as well as orthogonal and multiplaner reformatted 2D images. This ability to view the dataset in different perspectives from which it was acquired is performed by first transferring DICOM images from the MR or CT scanners to the Viatronix V3D Colon, which automatically identifies regions of interest and displays thesc regions to the user in the above mentioned views. The user can then navigate freely within the dataset/region of interest or follow automatically computed paths to fly through the colon or around the outside of the colon structure. Measurements of the size of colon polyps, masses or lesion can be made for patient screening and for planning treatment.

The Viatronix V3D Vascular is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MRI scans or 3D X-Ray angiography of the selected human vessels, e.g., the coronary arteries, the carotid arteries, the peripheral arteries, the aorta, arteries of the brain, and any opacified veins. The goal of this device is to automate routine inspection of human vessels to detect stenosis, plaque, bulge, aneurismal sac and dissection in the vessel. It also supports the interactive segmentation of any vessel by hiding certain parts of the data set from display for critical evaluation of selected part(s) of vessel. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, measure, evaluate, archive, print and distribute DICOM 3.0 compliant vessel image studies, utilizing PC hardware.

The V-3D Vascular is a software device for evaluating scanned images of selected vessels. The V3D Vascular module is designed to aid the physician in analyzing the vascular system based on images from a CT or MR scan or X-Ray angiography. The vessels include the coronary arteries, the carotid arteries, the peripheral arteries, the aorta, arteries of the brain, and any opacified veins. The goal is to automate routine inspection of the vessels as much as possible. It is an additional image processing option added to our V-3D visualization system for which pre-market clearance was granted by the FDA vide K#002780, dated November 17, 2000. It is a general software module, designed for use as a part of our V-3D visualization system core technology. The system consists of a V-3D processor and a V-3D viewer in two computer configuration or V-3D processor and V3D viewer in a stand alone one computer configuration. Upon receipt of a multislice CT or MR scan image for any selected vessel in a DICOM format, the V-3D processor converts the DICOM image data into an internally recognized volume data format using our core software. technology. The V-3D viewer provides interactive orthogonal and multiplanar reformatted 2D and 3D images from the V-3D processor and user can evaluate these images for any abnormality or malformation in specified vessels obtained from scanned images using the following methods: a ) The V3D Vascular shall initially segment out all the possible vessels of interest in the dataset. b } The V3D Vascular shall provide a selection view that allows selection of the vessels that the user wishes to visualize. Any vessels not desired or not actually vessels will then be hidden from view unless the user goes back to the view to re-select. When examining a vessel the module shall be used to aid in the following ways: c ) The V3D Vascular shall be used to aid the physician in the determination and localization of stenosis in the vessels. d ) The V3D Vascular shall be used to help determine the type of plaque in the vessels. e ) The V3D Vascular shall be used to determine the presence or absence of a bulge or an aneurysmal sac in the wall of the vessel. f ) The V3D Vascular shall be used to determine the presence or absence of a dissection. A dissection is a break in the interior lining of the vessel - the intima - that leads to pooled fluid between the intima and media that form the wall of the vessel. The intended user can use the software device to acquire, process, render, evaluate, archive, print and distribute DICOM 3.0 compliant images of any vessel, utilizing PC hardware.

The Viatronix V3D Explorer is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MRI, PET, SPECT scans and X-Ray of the human body including any organ. The volume, linear and angular measurement functions are intended for the evaluation and quantification of turnor or selected organ volume/linear measurements, angular location/ displacement, study/ analysis and evaluation of both hard and soft tissues as well as other internal organ structures for polyp, lesion, mass, implants, fracture, aneurysms, stenoses etc or evaluation of any abnormality / malformation in specified organs obtained from scanning and/or X-Ray. It also supports the interactive segmentation of any organ by removing certain structure(s) from display for critical evaluation of selected part(s) of organ. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, evaluate, archive, print and distribute DICOM compliant specified organ image studies, utilizing PC hardware.

The V-3D Explorer is a software device for evaluating CT/MRI scanned and X-Ray images of selected human organ. It is an additional image processing option added to our V-3D visualization system for which pre-market clearance was granted by the FDA vide K#002780, dated November 17, 2000. It is a general software module, designed for use as a part of our V-3D visualization system core technology. The system consists of a V-3D processor and a V-3D viewer in two computer configuration or V-3D processor and V3D viewer in a stand alone one computer configuration. Upon receipt of a multi-slice CT / MR scan image or X-Ray image for any selected organ in a DICOM format, the V-3D processor converts the DICOM image data into an internally recognized volume data format using our core software technology. The V-3D viewer provides interactive orthogonal and multiplanar reformatted 2D and 3D images from the V-3D processor and user can evaluate these images for any abnormality or malformation in specified organs obtained from scanned images or X-Ray images. The volume, linear and angular measurement features provided in the software for the evaluation and quantification of organ volume, linear measurements, angular location/displacement for hard and soft tissues as well as internal organ structures for polyp, lesion, mass, tumor, implants, fracture, aneurysms, stenoses etc. The software also supports interactive segmentation of any organ from removing certain structure from display for critical evaluation of selected part of organ. The intended user can use the software device to acquire, process, render, evaluate, archive, print and distribute DICOM 3.0 compliant images of any organ, utilizing PC hardware.

The Viatronix V3D Explorer is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MRI, PET and SPECT scans of the human body including any organ. The volume , linear and angular measurement functions are intended for the evaluation and quantification of turnor or selected organ volume/linear measurements, angular location/ displacement, study/ analysis and evaluation of both hard and soft tissues as well as other internal organ structures for polyp, lesion, mass, implants, fracture, aneurysms, stenoses etc or evaluation of any abnormality / malformation in specified organs obtained from scanning. It also supports the interactive segmentation of any organ by removing certain structure(s) from display for critical evaluation of selected part(s) of organ. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, evaluate, archive, print and distribute DICOM 3.0 compliant specified organ image studies, utilizing PC hardware.

The V-3D Explorer is a software device for evaluating scanned images of selected human organ. It is an additional image processing option added to our V-3D visualization system for which pre-market clearance was granted by the FDA vide K#002780, dated November 17, 2000. It is a general software module, designed for use as a part of our V-3D visualization system core technology. The system consists of a V-3D processor and a V-3D viewer in two computer configuration or V-3D processor and V3D viewer in a stand alone one computer configuration. Upon receipt of a multi-slice CT or MR scan image for any selected organ in a DICOM format, the V-3D processor converts the DICOM image data into an internally recognized volume data format using our core software. technology. The V-3D viewer provides interactive orthogonal and multiplanar reformatted 2D and 3D images from the V-3D processor and user can evaluate these images for any abnormality or malformation in specified organs obtained from scanned images. The volume, linear and angular measurement features provided in the software for the evaluation and quantification of organ volume, linear measurements, angular location/displacement for hard and soft tissues as well as internal organ structures for polyp, lesion, mass, tumor, implants, fracture, aneurysms, stenoses etc. The software also supports interactive segmentation of any organ from removing certain structure from display for critical evaluation of selected part of organ. The intended user can use the software device to acquire, process, render, evaluate, archive, print and distribute DICOM 3.0 compliant images of any organ, utilizing PC hardware.

The Viatronix V3D Colon is a system for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT and MR scans, for the purpose of screening a colon to detect polyps, masses, cancers and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon from rectum to cecum and vice versa for both prone and supine views. It generates a centerline for guided interactive navigation and fly through of the entire colon, and also includes a reporting facility to enhance workflow for screening a colon. It is intended for use by Radiologists, Clinicians and referring Physicians to process, render, review, archive, print and distribute colon image studies utilizing PC hardware.

The Viatronix V3D Colon contains all of the required hardware and software components to provide interactive 3D and 2D views of diagnostic CT and MR scan images of the colon. The views include both inner and outer surface 3D volume rendered images as well as orthogonal and multiplaner reformatted 2D images. This ability to view the dataset in different perspectives from which it was acquired is performed by first transferring DICOM images from the MR or CT scanners to the Viatronix V3D Colon, which automatically identifies regions of interest and displays these regions to the user in the above mentioned views. The user can then navigate freely within the dataset/region of interest or follow automatically computed paths to fly through the colon or around the outside of the colon structure. Measurements of the size of colon polyps, masses or lesions can be made for patient screening and for planning treatment.

The Viatronix V3D Calcium Scoring System is intended to be used by a trained physician for the review and analysis of CT images as an aid in cardiac analysis.

The V-3D Calcium Scoring System for Coronary Artery Calcification Scoring is an additional image processing option added to our V-3D visualization system for which pre-market clearance was granted by the FDA vide K#002780, dated November 17, 2000. The V-3D Calcium Scoring is an anatomy specific software module, designed for use as a part of our V-3D visualization system core technology. The system consists of a V-3D processor and a V-3D viewer. Upon receipt of a multi-slice CT scanner image for coronary arteries through DICOM, the V-3D processor converts the DICOM image data into an internally recognized volume data format using our core software technology. The V-3D viewer provides interactive 2D and 3D views from the V-3D viewer and determines the density and location of calcium deposits within the coronary arteries and also scores measurements of calcium deposits. The calcium score provides a quantitative evaluation of the extent of plaque accumulation in the coronary arteries.