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.
| Device | SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM |
| Classification Name | Automated Breast Ultrasound |
| Generic Name | Automated Breast Ultrasound |
| Applicant | U-SYSTEMS, INC. |
| Date Received | 2013-03-07 |
| Decision Date | 2013-06-17 |
| PMA | P110006 |
| Supplement | S001 |
| Product Code | PAA |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | U-SYSTEMS, INC. 9900 West Innovative Drive mail Stop Rp2138 wauwatosa, WI 53226 |
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