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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.
 
DeviceInvenia ABUS 2.0 Automated Breast Ultrasound System
Generic NameAutomated breast ultrasound
ApplicantU-SYSTEMS, INC.
9900 WEST INNOVATIVE DRIVE
MAIL STOP RP2138
WAUWATOSA, WI 53226
PMA NumberP110006
Supplement NumberS009
Date Received11/28/2017
Decision Date05/11/2018
Product Code PAA 
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 changes to the Invenia ABUS 2.0 Automated Breast Ultrasound System include hardware updates which include a new ultrasound beam former, ultrasound engine, and computer components. This supplement also requests approval for removal of the current review software from the PMA, and proposes that the images will now be reviewed on a workstation.
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