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Philips gets FDA 510(k) approval for Spectral Diagnostic Suite

Netherlands-based Royal Philips has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Spectral Diagnostic Suite (SpDS).

Philips

The SpDS is a set of advanced visualization and analysis tools developed for the Philips IQon Spectral CT to provide better spectral viewing and advanced clinical applications capabilities.

Philips SpDS package comprises spectral enhanced comprehensive cardiac analysis (sCCA), spectral enhanced advanced vessel analysis (sAVA) and spectral enhanced tumor tracking (sTT).

TBy offering spectral capabilities within traditional CT applications, the new tools allow clinicians to use the on-demand spectral information to achieve better clinical decision support without any added complexity of special modes or workstations.

It also helps in viewing and analyzing spectral datasets in a variety of settings, including a reading room, on picture archiving and communication systems (PACS), or from remote locations.

Philips CT senior vice president and general manager 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."

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


Image: Philips SpDS is a comprehensive solution for visualization and analysis of clinical spectral examinations. Photo: courtesy of PRNewswire/ Royal Philips.