FDA grants 510(k) clearance for Philips Spectral Diagnostic Suite

10 September 2015 (Last Updated September 10th, 2015 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Royal Philips to market its Spectral Diagnostic Suite (SpDS).

SpDS

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Royal Philips to market its Spectral Diagnostic Suite (SpDS).

The SpDS is a set of advanced visualisation and analysis tools that enable the Philips IQon Spectral CT to deliver improved spectral viewing and advanced clinical applications capabilities.

SpDS comprises spectral enhanced comprehensive cardiac analysis, advanced vessel analysis and enhanced tumour tracking.

The system enables clinicians to use on-demand spectral information to achieve better clinical decision support without any added complexity of special modes or workstations, which disrupt user workflow.

"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."

Additionally, the tools allow for viewing and analysis of spectral datasets in various settings, including a reading room, on picture archiving and communication systems, or from remote locations.

Philips CT senior vice-president Mikael Strindlund said: "The game changing capabilities of the Spectral Diagnostic Suite represent our ongoing commitment to drive advanced innovation in medical imaging to improve clinical output and diagnostic confidence, leading to better care for patients at lower dose exposure.

"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."

University Hospitals of Cleveland, UH Case Medical Centre, Department of Radiology assistant professor Dr Prabhakar Rajiah said: "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."

CT imaging is widely used in the diagnosis of different diseases and injuries, due to its accessibility, speed and assessment capabilities.

In August, Philips launched its web-enabled image and information management system, IntelliSpace Cardiovascular, in Europe.


Image: Philips SpDS allows for visualisation and analysis of clinical spectral examinations. Photo: courtesy of PRNewswire / Royal Philips.