FDA Clears Fujifilm’s FDR Visionary Suite, Company Launches FDR Clinica X-Ray Components

FUJIFILM Medical Systems U.S.A. Inc. today (3 Aug) announced the 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the marketing of its most recent innovation in digital radiography—the FDR Visionary Suite and the simultaneous release of its FDR Clinica X-Ray Components. While the Visionary Suite is a premiere digital x-ray suite designed for mid-to-large sized hospitals and health systems, the FDR Clinica X-ray Components were specifically created with outpatient facilities in mind.
 
“We take great pride in our ability to develop digital radiography solutions that uniquely benefit patient outcomes, technologist productivity, enhanced patient safety and bring maximum ROI,” said Rob Fabrizio, Director of Strategic Marketing, Digital Radiography and Women’s Health, FUJIFILM Medical Systems U.S.A., Inc. “These newly-released innovations are welcomed additions to our full portfolio of DR room offerings and meet the exacting standards in performance the market has come to expect from Fujifilm.”
 
The FDR Visionary Suite is Fujifilm’s next generation complete x-ray room system. It was designed to deliver optimized imaging workflow while expanding clinical capabilities. A flexible fully automated positioning system, offering a broad range of easy-to-use advanced applications including tomosynthesis, energy subtraction, and long length imaging—giving facilities the tools they need to better support challenging exams and diagnosis. The system’s automated features, coupled with Fujifilm’s advanced cesium iodide (CsI) detectors and unique image processing enhance positioning repeatability and workflow while optimizing image quality and diagnostic visibility for challenging views and fine detail exams. Fujifilm is presently taking orders for Visionary Suite; shipments are expected to begin as soon as September 2016.
 
The FDR Clinica X-ray Components provide a flexible, versatile solution offering a wide range of power ratings that can be matched to a facility’s specific requirements—be it a medium-sized x-ray department, a rural or remote facility with unstable power supply, or a large facility that demands a rigorous workload. Additional features and functions include rotating bucky tray; which saves time and reduces detector handling; an automatic detector connection; which improves efficiency and eliminates cable clutter; and an optional tilting wall stand so patients can be imaged while seated. Fujifilm’s FDR Clinica X-ray Components are currently available in the United States.