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This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of X-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

*As defined by professional medical societies. 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.

Siemens intends to market a new software version, SOMARIS/10 syngo CT VB20 for the following SOMATOM Computed Tomography (CT) Scanner Systems:

SOMATOM X. Platform CT scanner systems:

• SOMATOM X.cite
• SOMATOM X.ceed

In this submission, the above listed CT scanner systems are jointly referred to as subject devices by "SOMATOM X. Platform" CT scanner systems.

The subject devices SOMATOM X. Platform CT scanner systems with SOMARIS/10 syngo CT VB20 are Computed Tomography X-ray Systems which feature one continuously rotating tube-detector system and function according to the fan beam principle (single source). The SOMATOM X. Platform CT scanner systems with software SOMARIS/10 syngo CT VB20 produces CT images in DICOM format, which can be used by trained staff for software applications, e.g. post-processing applications, commercially distributed by Siemens Healthcare GmbH and other vendors as an aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.

Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists, or technologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system.

The platform software for SOMATOM X. Platform, SOMARIS/10 syngo CT VB20, is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

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