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• This application software is image processing application software available for installation onto customer-owned hardware. This application software can be networked to provide for sharing of resources. • This application software receives medical image data (CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, and RT Image) from modalities or image archives such as PACS through network or media, and provides for the viewing, quantification, manipulation, communication, printing and management of medical images. • This application software is intended only for use by trained medical professionals to supplement generally accepted methods of interpreting radiological images.

Ziostation2 is a basic DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation2 software. Various imaging tools and techniques can be invoked to process images from the following image types: CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, RT Image. CT Dual kV is a new image processing tool of Ziostation2 The added capabilities provided by this additional image processing tool for use with CT DICOM compliant images are: Generating and manipulating further images using volume data of two different tube voltage CT scans: - O Blend image - Subtraction image - 0 Virtual non-contrast image - lodine distribution map - O 2-Material decomposition image

• This application is image processing application software available for installation onto customer-owned hardware. This application software can be networked to provide for sharing of resources. • This application software receives medical image data (CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, and RT Image) from modalities or image archives such as PACS through network or media, and provides for the viewing, quantification, manipulation, communication, printing and management of medical images. •This application software is intended only for use by trained medical professionals to supplement generally accepted methods of interpreting radiological images. • Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor whose characteristics are approved by the regulatory agency governing the market within which this application is being offered.

Ziostation2 is a basic DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation2 software. Various imaging tools and techniques can be invoked to process images from the following image types: CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, RT Image.

MR Cardiac Function Analysis The MR Cardiac Function Analysis software option for use with Ziostation is intended for noninvasive post-processing of DICOM compliant cardiac MR images to semi-automatically calculate and display various functional parameters, such as left ventricular ejection fraction, end diastolic volume, end systolic volume, stroke volume, cardiac output, cardiac index, wall thickness, wall thickness ratio and regional wall motion display. These measurements can be used to assist the clinician in a cardiac evaluation.

MR Cardiac Function Analysis is an add-on software package designed to be used with the basic Ziostation image management system to further aid clinicians in their analysis of anatomy and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation software. The additional capabilities provided by this new device are: MR Cardiac Function Analysis software post-processes ECG-gated cardiac MR images and extracts the following left ventricular parameters from multi-phase data. - · Left ventricular ejection fraction - End diastolic volume - End systolic volume - Stroke volume - Cardiac output - Cardiac Index - Wall thickness - Wall thickness ratio - Wall movement - Volume Curve - Peak Ejection Rate - Peak Filling Rate

Cardiac Function Analysis: The Cardiac Function Analysis software option for use with Ziostation is intended for noninvasive post-processing of DICOM compliant cardiac CT images to semi-automatically calculate and display various functional parameters, such as left ventricular ejection fraction, end diastolic volume, end systolic volume, stroke volume, cardiac output, cardiac index, wall thickness, wall thickness ratio and regional wall motion display. These measurements can be used to assist the clinician in a cardiac evaluation. Calcium Scoring: The Calcium Scoring software option for use with Ziostation is a non-invasive post processing software tool that can be used with CT images to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease.

Cardiac Function Analysis and Calcium Scoring are add-on software packages designed to be used with the basic Ziostation image management system to further aid clinicians in their analysis of anatomy and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation software. The additional capabilities provided by these two new devices are: Cardiac Function Analysis software post-processes ECG-gated cardiac CT images and extracts the following left ventricular parameters from multi-phase data. - Left ventricular ejection fraction - End diastolic volume - End systolic volume - Stroke volume - Cardiac output - Cardiac Index - Wall thickness - Wall thickness ratio - Wall movement . - . Volume Curve Calcium Scoring software post-processes DICOM-based cardiac CT images and evaluates calcified plaque in the coronary arteries, providing the clinician with both Agatston and Volume calcium scores. These regions of interest are selected by the user.

Ziostation is an image processing workstation software package designed to run on standard PC hardware. It provides for the viewing, quantification, manipulation, printing, and management of medical images. It is intended for use by trained medical professionals to aid in their reading and review of such data. In addition, Ziostation has the following indication: The CT Brain Perfusion for Ziostation option is an image analysis software package providing additional image processing capabilities to the basic Ziostation device. The CT Brain Perfusion Option is intended for post-processing based on dynamic CT images continuously acquired during the injection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.

CT Brain Perfusion for Ziostation is an add-on software feature designed to provide a color map of cerebral blood flow and pictorial illustration of perfusion-related parameters obtained on CT images of the brain. This software is designed to work within the currently cleared Ziostation image management device.

ZIOSTATION is an image processing workstation software package designed to run on standard PC hardware. The required hardware consists of standard 'off-the-shelf' computer components. It receives image data from standard modalities (medical image scanning devices) or from image archives. It provides for the viewing, quantification, manipulation, communication, printing, and management of medical images. It can be used as a just a workstation or as a client-server within a network. It is intended for use by trained medical imaging professionals to aid in their reading and review of such data. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammograpic images may only be interpreted using an FDA approved monitor that offers at least 5 MPixel resolution and meets other technical specifications reviewed and accepted by FDA.

ZIOSTATION is a software-only imaging workstation that installs on one or more of a customer's standard PCs and integrates with a customer's 'off the shelf' PC-based computer components to provide viewing, quantification, manipulation, communication, printing, and management capabilities for medical images. It provides access to both local and centralized (networked) image data. ZIOSTATION can acquire and work with image data from multiple DICOM-compliant modalities and image archives. It provides querying and listing based on user-selected criteria. It provides for multiple types of 2D and 3D image displays. It provides interactive menus and tools for image manipulation and measurement. ZIOSTATION provides workflow enhancement and optional specialist tools for clinical applications. ZIOSTATION uses only lossless compression for images used for diagnostic purposes. It does use lossy compression when exporting to JPEG and AVI files, but its labeling indicates that those files are not to be used for clinical evaluations.