Approval for the breast companion software system. The breast companion is a computer-aided system intended for improving the acr bi-rads assessment of ultrasound images of lesions of the female breast as part of the diagnostic workshop.
| Device | BREAST COMPANION SOFTWARE SYSTEM |
| Generic Name | Analyzer, Medical Image |
| Applicant | ALMEN LABORATORIES, INC. |
| Date Received | 2010-02-17 |
| Decision Date | 2012-02-10 |
| Notice Date | 2012-03-06 |
| PMA | P100007 |
| Supplement | S |
| Product Code | MYN |
| Docket Number | 12M-0172 |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ALMEN LABORATORIES, INC. 1672 Gil Way vista, CA 92084 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100007 | Original Filing |