Philips Receives FDA 510(k) Clearance for Spectral Diagnostic Suite

On-demand visualization and analytics solution for Philips IQon Spectral CT delivers expanded clinical applications and drives diagnostic confidence

September 9, 2015

ANDOVER, MA – Reinforcing its commitment to improving diagnostic confidence through innovation, Royal Philips (NYSE: PHG AEX: PHIA) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Spectral Diagnostic Suite (SpDS). Philips SpDS is a set of advanced visualization and analysis tools designed for the Philips IQon Spectral CT to deliver enhanced spectral viewing and advanced clinical applications capabilities.

Due to its accessibility, speed and assessment capabilities, CT imaging is widely used in the diagnosis of many different diseases and injuries. By providing spectral capabilities within traditional CT applications, SpDS offers a new level of flexibility and clinical information for CT users, allowing clinicians to utilize the spectral information “on-demand,” to achieve better clinical decision support without any added complexity of special modes or workstations that disrupt user workflow. Additionally, because there is no need to bring the patient back for additional imaging, on-demand spectral analysis of a particular region allows the physician to further analyze incidental findings and at the same time reduce dose exposure to the patient.  

"Philips Spectral suite offers a new level of control for clinicians, allowing for segmentation on different energy levels, more detailed comparison between images, and advanced fusion capabilities, for diagnostic confidence,” said Dr. Prabhakar Rajiah, MBBS, M.D., FRCR, Assistant Professor of Radiology, University Hospitals of Cleveland, UH Case Medical Center, Department of Radiology, who collaborated with Philips on the development of the suite.

The Philips SpDS package includes:
  • Spectral enhanced Comprehensive Cardiac Analysis (sCCA)
  • Spectral enhanced Advanced Vessel Analysis (sAVA)
  • Spectral enhanced Tumor Tracking (sTT).

The Philips SpDS also allows for viewing and analysis of spectral datasets in a variety of settings: a reading room, on picture archiving and communication systems (PACS), or from remote locations.

“The game-changing capabilities of the Spectral Diagnostic Suite represent our ongoing commitment to drive advanced innovation in medical imaging toimprove clinical output and diagnostic confidence, leading to better care for patients at lower dose exposure,” said Mikael Strindlund, Senior Vice President & General Manager, CT, for Philips.  “Providing clinicians with additional data to help support the right clinical decisions while improving workflow and patient experience, is at the core of everything we do.”

For more information on Philips IQon Spectral CT and the Philips Spectral Diagnostic Suite, please visit:
Spectral Diagnostic Suite

Spectral Diagnostic Suite

For further information, please contact:

Kathy O’Reilly
Philips Group Communications
+1 978-659-2638 (mobile) +1 978-221-8919
Twitter: @kathyoreilly

Adrienne Smith
Tel: +978 659-2826


About Royal Philips:

Royal Philips (NYSE: PHG, AEX: PHIA) is a diversified health and well-being company, focused on improving people's lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle and Lighting. Headquartered in the Netherlands, Philips posted 2014 sales of EUR 21.4 billion and employs approximately 106,000 employees with sales and services in more than 100 countries. The company is a leader in cardiac care, acute care and home healthcare, energy efficient lighting solutions and new lighting applications, as well as male shaving and grooming and oral healthcare. News from Philips is located at


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