Approval for the senoclaire. This device is indicated for the acquisition of 2d images and also for the acquisition of multiple projection views intended to produce 3d dbt images suitable for screening and diagnosis of breast cancer. Senoclaire can be used for the same clinical applications as traditional mammography for screening mammography. A screening examination will consist of:1) 2d image set consisting of a craniocaudal view and of a mediolateral oblique view, or 2) a 2d craniocaudal view and 3d mediolateral oblique image set. The senoclaire digital breast tomosynthesis (dbt) option to senographe essential ffdm system may also be used for additional diagnostic workup of the breast.
| Device | SENOCLAIRE |
| Classification Name | Digital Breast Tomosynthesis |
| Generic Name | Digital Breast Tomosynthesis |
| Applicant | GE Healthcare |
| Date Received | 2013-07-17 |
| Decision Date | 2014-08-26 |
| Notice Date | 2014-09-02 |
| PMA | P130020 |
| Supplement | S |
| Product Code | OTE |
| Docket Number | 14M-1279 |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GE Healthcare 3000 N. Grandview Blvd waukesha, WI 53188 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P130020 | | Original Filing |
| S004 |
2020-05-04 |
Normal 180 Day Track |
| S003 |
2017-10-26 |
Real-time Process |
| S002 |
2016-08-12 |
Normal 180 Day Track |
| S001 |
2016-07-19 |
Normal 180 Day Track |
NIH GUDID Devices