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Device | SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM) |
Generic Name | Automated breast ultrasound |
Applicant | U-SYSTEMS, INC. 9900 WEST INNOVATIVE DRIVE MAIL STOP RP2138 WAUWATOSA, WI 53226 |
PMA Number | P110006 |
Date Received | 02/11/2011 |
Decision Date | 09/18/2012 |
Product Code |
PAA |
Docket Number | 12M-1011 |
Notice Date | 09/25/2012 |
Advisory Committee |
Radiology |
Clinical Trials | NCT00816530
|
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH 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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 |