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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

The provided text is a 510(k) Summary for the Ziostation2 device. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, the document does not contain specific details about acceptance criteria, device performance metrics, the studies conducted (including sample sizes, ground truth establishment, expert qualifications, or adjudication methods), or any mention of MRMC comparative effectiveness studies or standalone performance evaluations.

Therefore, I cannot provide the requested information based solely on the given text. The text only mentions "integration testing/verification testing" and "regression testing" without elaborating on their specifics or results against defined acceptance criteria.

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