Siemens Healthineers Receives FDA Clearance for SOMATOM Confidence RT Pro CT System

Dec 20, 2016

· New dedicated CT scanner delivers RT images that enable precise contouring and personalized dose calculation while eliminating unnecessary workflow steps

· New syngo.via RT Image Suite software complements SOMATOM Confidence RT Pro with integrated image assessment, contouring, and patient marking features


Siemens Healthineers has received 510(k) clearance from the Food and Drug Administration (FDA) for the SOMATOM Confidence® RT Pro computed tomography (CT) scanner with features dedicated to radiation therapy (RT) planning. Together with the new, advanced version of the company’s optional syngo.via RT Image Suite software, the SOMATOM Confidence RT Pro helps customers achieve personalized scans while simultaneously enabling them to reach unprecedented heights of standardization and efficiency. Through products and solutions such as the SOMATOM Confidence RT Pro that are designed to increase efficiency and to reduce costs, Siemens Healthineers – the separately managed healthcare business of Siemens AG – is setting new trends in healthcare together with its customers, helping to enable healthcare providers around the world to meet their current challenges and to excel in their respective environments.


The new SOMATOM Confidence RT Pro is designed to deliver new RT images that challenge current practices in RT treatment planning, which favor standardization over personalization. For example, the standard RT treatment plan of every patient – regardless of age, gender, disease state, or imaging system – is built on 120 kV CT images, which aren’t optimized for precise contouring but enable a highly controlled workflow.


Taking into account the trend toward more advanced treatment techniques where precision is critical to high-quality care, the SOMATOM Confidence RT Pro enables personalized scans by delivering images that are optimized for both contouring and dose calculation. No longer limited to the traditional 120 kV tube voltage, radiation oncology professionals can now, through the SOMATON Confidence RT Pro and its new DirectDensity™1 technology, provide personalized imaging for each RT patient.


The SOMATOM Confidence RT Pro features the DirectDensity™1 algorithm, which can be used to reconstruct images where values can be interpreted as showing relative electron density2 at any given kV setting, enabling seamless use of those images for treatment planning. And thanks to iMAR metal artifact reduction, task-based automated kV settings with CARE kV, and an all-new detector that enhances image quality and dual energy performance, the SOMATOM Confidence RT Pro can generate personalized images for all RT patients – images intended to enable optimal precision along the entire RT chain, for both confident contouring and dose calculation.


Additionally, the new syngo.via RT Image Suite software from Siemens Healthineers complements the SOMATOM Confidence RT Pro by helping radiation oncology professionals increase efficiency with integrated image assessment, contouring, and patient marking features in one solution. Its flexible client-server based architecture enables easy adaptation to the needs of RT staff regardless of location – be it the CT console, the physician’s office, or the dosimetry lab. And developed with an eye toward scalability, syngo.via RT Image Suite grows with the needs of the RT department, from straightforward simulation tools to complex, interdepartmental, multi-modality workflow and task support.


syngo.via RT Image Suite fully unlocks the potential of the RT images and can help users open new clinical avenues, potentially enabling them to consume complex studies such as multi-parametric magnetic resonance (MR) images, dual energy and perfusion CT images, and 4D positron emission tomography (PET)/CT images, among others.



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Siemens Healthineers is the separately managed healthcare business of Siemens AG enabling healthcare providers worldwide to meet their current challenges and to excel in their respective environments. A leader in medical technology, Siemens Healthineers is constantly innovating its portfolio of products and services in its core areas of diagnostic and therapeutic imaging and in laboratory diagnostics and molecular medicine. Siemens Healthineers is also actively developing its digital health services and enterprise services. To help customers succeed in today’s dynamic healthcare marketplace, Siemens Healthineers is championing new business models that maximize opportunity and minimize risk for healthcare providers. In fiscal 2016, which ended on September 30, 2016, Siemens Healthineers generated revenue of €13.5 billion and profit of over €2.3 billion and has about 46,000 employees worldwide. Further information is available at

1DirectDensity reconstruction is designed for use in Radiation Therapy Planning (RTP) only. DirectDensity reconstruction is not intended to be used for diagnostic imaging.

2As shown by measurements with a Gammex 467 Tissue Characterization Phantom comparing standard reconstruction (kernel D30) and DirectDensity reconstruction (kernel E30). HU value to relative electron density conversion for the standard reconstruction was based on a two-linear-equations approach with individual calibration for each tube voltage. For DirectDensity images, a single tube-voltage-independent linear conversion was used.