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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 NameSENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Generic Namedigital mammographic x-ray system
Regulation Number892.1715
ApplicantGE HEALTHCARE
PMA NumberP990066
Supplement NumberS019
Date Received04/18/2005
Decision Date05/25/2005
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in two software modifications that have been made to the acquisition workstation (aws) and for an additional supplier for the conditioner (chiller for the image receptor). The device, as modified, will be marketed under the trade name senographe ds full field digital mammography system and is indicated as follows: the senographe ds full field digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer. The senographe ds full field digital mammography system is intended to be used in the same clinical applications as traditional film-based mammographic system.
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