Fujifilm Announces 510(k) Clearance of FDR Visionary Suite and the Release of FDR Clinica X-Ray Components

STAMFORD, Conn.--()--FUJIFILM Medical Systems U.S.A., Inc., a leading provider of diagnostic imaging products and medical informatics solutions, today 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.

Fujifilm’s FDR Clinica X-ray Components offer high-quality, cost-effective digital x-ray solutions with features designed to enhance workflow and improve patient care, particularly in active outpatient settings. 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.

For more information about Fujifilm, please visit: www.fujifilmhealthcare.com.

About Fujifilm

FUJIFILM Medical Systems U.S.A., Inc. is a leading provider of diagnostic imaging products and medical informatics solutions to meet the needs of healthcare facilities today and well into the future. From an unrivaled selection of digital x-ray systems, to the Synapse® brand of PACS, RIS and cardiovascular products, to advanced women’s health imaging systems, Fujifilm has products that are ideal for any size imaging environment. The Endoscopy Division of FUJIFILM Medical Systems U.S.A., Inc. supplies high quality, technologically advanced FUJINON brand endoscopes to the medical market. TeraMedica Division delivers healthcare informatics, and is the leading provider of vendor neutral, enterprise-wide solutions for unrestricted medical image management. FUJIFILM Medical Systems U.S.A., Inc. is headquartered in Stamford, CT. For more information please visit www.fujifilmhealthcare.com and www.fujifilmendoscopy.com.

FUJIFILM Holdings Corporation, Tokyo, Japan brings continuous innovation and leading-edge products to a broad spectrum of industries, including: healthcare, with medical systems, pharmaceuticals and cosmetics; graphic systems; highly functional materials, such as flat panel display materials; optical devices, such as broadcast and cinema lenses; digital imaging; and document products. These are based on a vast portfolio of chemical, mechanical, optical, electronic, software and production technologies. In the year ended March 31, 2016, the company had global revenues of $22.1 billion, at an exchange rate of 112.54 yen to the dollar. Fujifilm is committed to environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com.

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Contacts

Fujifilm
Lauren Geloso, 914-789-8303
lgeloso@fujifilm.com

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Contacts

Fujifilm
Lauren Geloso, 914-789-8303
lgeloso@fujifilm.com