SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface Assembly
FDA premarket approval P200040 · decided 2021-10-06
Approval details
- PMA number
- P200040
- Trade name
- 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
- Days to decision
- 398 days
- Decision code
- APPR
- Product code
- PAA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Novi, MI
- Statement
- 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 b
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SoftVue (K172256) | Delphinus Medical Technologies | 2018-03-02 |