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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSIEMENS MAMMOMAT NOVATION FFDM 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
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/material
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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