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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.
 
DeviceSENOGRAPHE DS & 2000D 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
GE Healthcare
3000 n. grandview blvd
waukesha, WI 53188
PMA NumberP990066
Supplement NumberS020
Date Received05/03/2005
Decision Date07/01/2005
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 for software changes to the senographe ds and (2000d) ffdm acquition workstation (aws) and review workstation to allow users to select the premium view (pv) algorithm as primary image processing.
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