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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.
 
DeviceSIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital,system,x-ray,mammographic
Regulation Number892.1715
Applicant
SIEMENS MEDICAL SOLUTION
51 valley stream pkwy.
malvern, PA 19355
PMA NumberP030010
Date Received04/10/2003
Decision Date08/20/2004
Reclassified Date 12/06/2010
Product Code
MUE[ Registered Establishments with MUE ]
Docket Number 04M-0387
Notice Date 09/03/2004
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the siemens mammomat novationdr full field digital mammography system. The device generates digital mammographic images that can be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional film-based mammographic systems. These mammographic images can be interpreted by either hardcopy film or by softcopy at a workstation.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 
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