Device Description
The Fuji Computed Radiography (FCR) system with FCRMS installed (FCRm) replaces the screen-film receptor and chemical processing system to produce a digital image.
FCRm should be used with mammographic X-ray machines and output display devices that are cleared by the United States Food and Drug Administration (FDA) for primary image interpretation in mammography.
Indications for Use
The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with specified Fuji Computed Radiography system, forms the Fuji Computed Radiography for mammography (FCRm) device.
FCRm is intended for use in the same clinical applications as traditional screen-film based mammographic (SFM) systems.
Warnings and Precautions
Calibration of the FCRm image reader and X-ray system is required prior to use.
Insertion of a broken cassette into an FCRm reader can result in mechanical failure and system shutdown.
FCRm does not emit radiation; however, it is used in conjunction with X-ray emitting equipment.
Manual:
Download: Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information
Chat: Powered By VoiceSphere