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.
| Device | SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM) |
| Classification Name | Automated Breast Ultrasound |
| Generic Name | Automated Breast Ultrasound |
| Applicant | U-SYSTEMS, INC. |
| Date Received | 2011-02-11 |
| Decision Date | 2012-09-18 |
| Notice Date | 2012-09-25 |
| PMA | P110006 |
| Supplement | S |
| Product Code | PAA |
| Docket Number | 12M-1011 |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | U-SYSTEMS, INC. 9900 West Innovative Drive mail Stop Rp2138 wauwatosa, WI 53226 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P110006 | | Original Filing |
| S010 |
2017-11-29 |
Normal 180 Day Track No User Fee |
| S009 |
2017-11-28 |
Normal 180 Day Track |
| S008 |
2017-02-28 |
Normal 180 Day Track No User Fee |
| S007 |
2016-08-03 |
Normal 180 Day Track |
| S006 |
2015-09-18 |
30-day Notice |
| S005 |
2015-02-27 |
Real-time Process |
| S004 |
2014-11-03 |
Real-time Process |
| S003 |
2014-02-26 |
30-day Notice |
| S002 |
2014-01-17 |
Real-time Process |
| S001 |
2013-03-07 |
Normal 180 Day Track |
NIH GUDID Devices