FDA 510(k) Clearance for Philips IQon Spectral CT

Royal Philips has announced U.S. FDA 510(k) clearance for its IQon Spectral CT, which it says presents an entirely new approach to spectral imaging.


Due to its accessibility, speed and accuracy, CT imaging is widely used in the diagnosis of many different diseases and injuries. Now, Philips’ first-of-its kind technology has added a new dimension to Computed Tomography (CT) imaging, delivering anatomical information and offering the ability to characterize structures based on their material content within a single scan. The enhanced image quality may help improve confidence in diagnoses and deliver operational efficiency.

Philips IQon Spectral CT was developed in close collaboration with clinicians and is designed to overcome some of their most immediate challenges, including workflow and image management issues. The technology can discriminate between X-ray photons of multiple high and low energies – similar to the principal behind a prism splitting white light into the rainbow of colors. Through the Spectral CT scan, clinicians can access the conventional grey-scale anatomical images, along with the spectral information within the same scan. As a result, Philips IQon Spectral CT enables real-time, retrospective data analysis, without disrupting a clinician’s workflow and takes the guesswork out of multi-energy acquisitions, making it easy to use and allowing for routine spectral use.

Physician comments

“Spectral imaging has the potential to change the way clinicians practice radiology in the future,” said Jacob Sosna, President of the Israeli Radiology Society and Chairman of the Department of Radiology at Hadassah Hebrew University Medical Center, who collaborated with Philips on the development the product. “A recent study with Philips IQon Spectral CT revealed enhanced diagnosis in up to 70 percent of cases. Using the prospective approach, we would only have access to spectral information in 20 or 25 percent, at maximum.”

Company comments 

“The IQon Spectral CT represents our commitment to leading a new, higher standard for medical imaging that is driven by clinical insights and focused on the patient experience,” said Gene Saragnese, CEO Imaging Systems, Philips Healthcare. “Delivering an additional level of spectral information without impacting clinician workflow is vital for confident diagnoses that can significantly add value to help improve patient care.”

Source: Royal Philips, PR Newswire

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