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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.
 
DeviceSOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM
Generic NameAutomated breast ultrasound
ApplicantU-SYSTEMS, INC.
9900 WEST INNOVATIVE DRIVE
MAIL STOP RP2138
WAUWATOSA, WI 53226
PMA NumberP110006
Supplement NumberS001
Date Received03/07/2013
Decision Date06/17/2013
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 A NEW TRANSDUCER, NEW PRE-SET COMPRESSION ASSIST FUNCTION, AND OTHER SOFTWARE AND COMPUTER HARDWARE CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INVENIA ABUS AND IS INDICATED AS AN ADJUNCT TO MAMMOGRAPHY FOR BREASTCANCER SCREENING IN ASYMPTOMATIC WOMAN FOR WHOM SCREENING MAMMOGRAPHY FINDINGS ARE NORMAL OR BENIGN (BI-RADS ASSESSMENT CATEGORY 1 OR 2), WITH DENSE BREAST PARENCHYMA (BIRADSCOMPOSITION/DENSITY 3 OR 4), AND HAVE NOT HAD PREVIOUS CLINICAL BREAST INTERVENTION. THE DEVICE IS INTENDED TO INCREASE BREAST CANCER DETECTION IN THE DESCRIBED PATIENT POPULATION.
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