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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.
Generic Namedigital breast tomosynthesis
ApplicantGE Healthcare
3000 n. grandview blvd
waukesha, WI 53188
PMA NumberP130020
Supplement NumberS001
Date Received07/19/2016
Decision Date01/05/2017
Product Code OTE 
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for GE SenoClaire Digital Breast Tomosynthesis system indicated for acquisition of multiple projection views to produce 3D digital mammography images suitable to be used in screening and diagnosis of breast cancer. A screening examination may consist of a 3D DBT image set consisting of a CC and MLO view, and a 2D synthesized image set consisting of a CC and MLO V-Preview images.