Approval for a change in applications training program for the invenia abus automated breast ultrasound system. Two additional training programs were proposed. The first addition consists of a one-day training program for one technologist/scan operator, equivalent to the previously-approved three-day program for three technologists/scan operators. The second addition consists of a one-day training program for a designated siteoperations specialist who is experienced in invenia abus breast exams, and is qualified for the training according to a set of specified requirements outlined by the sponsor.
| Device | INVENIA ABUS- AUTOMATED BREAST ULTRASOUND SYSTEM |
| Classification Name | Automated Breast Ultrasound |
| Generic Name | Automated Breast Ultrasound |
| Applicant | U-SYSTEMS, INC. |
| Date Received | 2015-02-27 |
| Decision Date | 2015-04-13 |
| PMA | P110006 |
| Supplement | S005 |
| Product Code | PAA |
| Advisory Committee | Radiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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