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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceFUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital,system,x-ray,mammographic
Regulation Number892.1715
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 west ave.
stamford, CT 06902
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 
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