FDA gives 510(k) approval for the MicroDose SI SPECT imaging system (Philips)

The FDA has given 510(k) clearance for the MicroDose SI system, from Philips, which is a full-field digital mammography (FFDM) system with the capability to enable future Single-Shot Spectral Imaging applications. The MicroDose SI uses digital photon-counting technology, which enables clinicians to conduct exams using low radiation dose without compromising image quality. The technology allows clinicians to see more than just a shadow in mammogram images by separating high and low energy X-ray within one single exposure.