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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 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Generic Namedigital mammographic x-ray system
Regulation Number892.1715
ApplicantGE MEDICAL SYSTEMS
PMA NumberP990066
Supplement NumberS016
Date Received09/02/2003
Decision Date02/19/2004
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in ergonomics, the image acquisition chain, image presentation on the aws, and connectivity. In addition the application requested additional image quality claims and qc manual changes for qc test technique factors and procedures under mqsa. The device, as modified, will be marketed under the trade name senographe 2100d full field digital mammography system.
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