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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)
Generic NameAutomated breast ultrasound
ApplicantU-SYSTEMS, INC.
9900 WEST INNOVATIVE DRIVE
MAIL STOP RP2138
WAUWATOSA, WI 53226
PMA NumberP110006
Date Received02/11/2011
Decision Date09/18/2012
Product Code PAA 
Docket Number 12M-1011
Notice Date 09/25/2012
Advisory Committee Radiology
Clinical TrialsNCT00816530
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE SOMO-V: AUTOMATED BREAST ULTRASOUND SYSTEM (ABUS). THIS DEVICE IS INDICATED AS AN ADJUNCT TO MAMMOGRAPHY FOR BREAST CANCER SCREENING IN ASYMPTOMATIC WOMEN FOR WHOM SCREENINGMAMMOGRAPHY FINDINGS ARE NORMAL OR BENIGN (BI-RADS ASSESSMENT CATEGORY 1 OR 2), WITH DENSE BREAST PARENCHYMA (BI-RADS COMPOSITION/DENSITY 3 OR 4) AND HAVE NOT HAD PREVIOUS CLINICALBREAST INTERVENTION. THE DEVICE IS INTENDED TO INCREASE BREAST CANCER DETECTION IN THE DESCRIBED PATIENT POPULATION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 
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