Approval for changes to the invenia abus 2. 0 automated breast ultrasound system include hardware updates which include a new ultrasound beam former, ultrasound engine, and computer components. This supplement also requests approval for removal of the current review software from the pma, and proposes that the images will now be reviewed on a workstation.
| Device | Invenia ABUS 2.0 Automated Breast Ultrasound System |
| Classification Name | Automated Breast Ultrasound |
| Generic Name | Automated Breast Ultrasound |
| Applicant | U-SYSTEMS, INC. |
| Date Received | 2017-11-28 |
| Decision Date | 2018-05-11 |
| PMA | P110006 |
| Supplement | S009 |
| Product Code | PAA |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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