FDA approves Revolution CT scanner for Imaging - GE HealthCare
The FDA has given 510(k) clearance of the Revolution CT scanner from GE HealthCare, for patient Imaging. The scanner offers advances including 16 cm whole organ coverage, improved spatial resolution through the new Gemstone Clarity Detector, and a new gantry designed to image at 0.28s rotation speed and tested to support rotation speeds up to 0.2 sec in the future.
It also features ASiR-V, GE's next generation of iterative reconstruction technology also recently cleared by FDA and designed to deliver reduced noise levels, improve low-contrast detectability, and routinely reduce dose up to 82% for patients of all ages with uncompromised image quality. This especially benefits pediatric and other patients considered more sensitive to radiation exposure. The scanner is not cleared in the EU.