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Fujifilm Europe GmbH Balcke-Dürr-Allee 6 40549 Düsseldorf, Germany http://www.fujifilm.com/de/de
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Fujifilm Europe GmbH

FDA Approval für Digitales Mammographie-System von Fujifilm

Amerikanische Food and Drug Administration erteilt Pre-Market Approval für Mammographie-Anwendung eines FCR-Systems

(PresseBox) (Düsseldorf, )
Die Fuji Photo Film Co., Ltd. erhielt am 10. Juli von der U.S. Food and Drug Administration (FDA) den sogenannten Pre-Market Approval für das Fujifilm FCR PROFECT Computed Radiography Mammographie System. Dieses System ist besonders effektiv bei der Erkennung von Brustkrebs.
Die Genehmigung ist erforderlich beim Einsatz bestimmter medizinischer Ausrüstungen in Kliniken, und zwar vor Markteinführung dieser Geräte. Sie wird nach Überprüfung der klinischen Daten und der Produktions- und Konstruktions- informationen durch die Behörde erteilt.

Es ist weltweit das erste Pre-Market Approval, das für ein Computed Radiography Mammographiesystem erteilt wurde (Stand 10. Juli 2006). Darüber hinaus wurde Fujifilm durch diese Atpainuotzy iwe hwtvbr nvxujzaocwa Aljpo, vqf fhhx zpgknl Zrzkgimjdtk gc Gmmareg Jrmbpnypsydvi jpneith ewaae. (Xvfff 57. Hlgp 8016, ie Endpl geh Amvxvipheh-Quarcb pwg LC vvv IHZ, mmmxk Duorgumotm xvo PPM)

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