Fujifilm Announces 510(k) Clearance of Detectors for Pediatric Use

RSNA 2013
Booth #2539 South Building

STAMFORD, Conn.--()--(Booth #2539 South Building)-FUJIFILM Medical Systems U.S.A., Inc. announced today 510(k)clearance from the U.S Food and Drug Administration (FDA) of its Gadolinium and Cesium digital X-ray detectors for pediatric use. Sizes that are available include: 24x30cm, 14x17 and 17x17. The smallest format 24x30cm cesium iodide detector is specifically designed to offer high DQE performance for low dose x-ray exams such as for small patients and anatomy such as extremities, shoulders, c-spines and more.

“Fujifilm has always been committed to patient safety and we continue set a high standard in establishing safe, low-dose pediatric imaging. We have helped lead the way with our commitment to reducing radiation and investing in new imaging technology innovations that allow us to offer a safe and effective imaging for every size patient and anatomy,” said Rob Fabrizio, director of marketing and product development, Digital X-ray, FUJIFILM Medical Systems U.S.A., Inc. “With this clearance, radiologists, technologists and administrators can count on Fujifilm to bring quality images for fast, confident diagnoses for our most precious patients; infants and children.”

Fujifilm is proud to support the image gently® campaign introduced by the Alliance for Radiation Safety in Pediatric Imaging to raise awareness and educate health professionals and parents about the need to lower and limit the exposure of children to radiation.

To register for a product demonstration at RSNA, please visit http://rsna.fujimed.com. For every product demonstration registered online, Fujifilm will donate $25 to the National Breast Cancer Foundation. For more information about Fujifilm digital radiography solutions, please visit: http://digital-radiology.fujimed.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. FUJIFILM Medical Systems U.S.A., Inc. is headquartered in Stamford, CT. For more information, please visit www.fujimed.com and www.fujifilmendoscopy.com.

FUJIFILM Holdings Corporation, Tokyo, Japan, brings continuous innovation and leading-edge products to a broad spectrum of industries, including electronic imaging, digital printing equipment, medical systems, life sciences, graphic arts, flat panel display materials, and office products, based on a vast portfolio of digital, optical, fine chemical and thin film coating technologies. The company was among the top 10 companies around the world granted U.S. patents in 2012, and in the year ended March 31, 2013, had global revenues of $26.7 billion*. Fujifilm is committed to environmental stewardship and good corporate citizenship. For more information, please visit www.fujifilmholdings.com.

* At an exchange rate of 83 yen to the dollar.

Contacts

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

Fujifilm's 24x30cm digital x-ray detector (Photo: Business Wire)

Fujifilm's 24x30cm digital x-ray detector (Photo: Business Wire)

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Contacts

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