FDA gives 510(k) approval for IQon Spectral CT Imaging System - Philips

Philips has announced 510(k) clearance from the FDA for its IQon Spectral CT Imaging System. 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. A recent study with Philips IQon Spectral CT revealed enhanced diagnosis in up to 70 percent of cases, compared to 20 or 25 percent conventionally. The IQon Spectral CT system is currently available for ordering in 36 countries.