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

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

RSNA 2013 Booth #2539 South Building

Business Wire

STAMFORD, Conn. -- December 2, 2013

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

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

“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.

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Contact:

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