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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.
 
DeviceSENOCLAIRE
Classification Namedigital breast tomosynthesis
Generic Namedigital breast tomosynthesis
Applicant
GE Healthcare
3000 n. grandview blvd
waukesha, WI 53188
PMA NumberP130020
Supplement NumberS001
Date Received07/19/2016
Decision Date01/05/2017
Product Code
OTE[ Registered Establishments with OTE ]
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 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.
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