Approval for the softvue system. The device is indicated as an adjunct to mammography for breast cancer screening in asymptomatic women with dense breast parenchyma after confirmation that the breast density composition is bi-rads c or d at the time of screening mammography. The device is intended to increase breast cancer detection in the described patient population relative to mammography alone. The device is not intended to be used as a replacement for screening mammography. The device can be used at the same visit as screening mammography and softvue images are intended to be interpreted with the mammogram results to enhance screening.
| Device | SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly |
| Generic Name | Automated Breast Ultrasound |
| Applicant | Delphinus Medical Technologies |
| Date Received | 2020-09-03 |
| Decision Date | 2021-10-06 |
| PMA | P200040 |
| Supplement | S |
| Product Code | PAA |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Delphinus Medical Technologies 45525 Grand River Avenue novi, MI 48374 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P200040 | | Original Filing |
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NIH GUDID Devices