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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameFUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefuji cr-ir348cl image with fcrms software
Regulation Number892.1715
ApplicantFUJIFILM MEDICAL SYSTEM U.S.A., INC.
PMA NumberP050014
Date Received03/30/2005
Decision Date07/10/2006
Reclassified Date 12/06/2010
Product Code
MUE[ Registered Establishments with MUE ]
Docket Number 06M-0295
Notice Date 07/25/2006
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the fuji computed radiography mammography suite (fcrms). The fcrms is a software device that, in conjunction with a specified fuji computed radiography system, forms the fuji computed radiography for mammography (fcrm) device. Fcrm with a dedicated mammographic x-ray machine generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic (sfm) systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.
Approval Order Approval Order
Supplements: S001 S002 
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