FUJIFILM Announces 510(k) Clearance

FUJIFILM Medical Systems U.S.A. Inc., has announced the 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the marketing of its FDR Visionary Suite and the simultaneous release of its FDR Clinica X-Ray Components. While the Visionary Suite is a 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.