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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSIEMENS MAMMOMAT NOVATION FFDM SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital mammography system
Regulation Number892.1715
ApplicantSIEMENS MEDICAL SOLUTION
PMA NumberP030010
Supplement NumberS001
Date Received01/19/2005
Decision Date07/07/2005
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change the acquisition workstation (aws) from the currently approved unix-based sun workstation with solaris 8 operating system to a fujitsu/siemens m420pc with syngo operating system and the proposed changes allowing the software drivers for the detector interface (drul) to be windows xp based.
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