Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly
• Generic Name: Automated breast ultrasound
• Applicant: Delphinus Medical Technologies; 45525 Grand River Avenue; Novi, MI 48374
• PMA Number: P200040
• Date Received: 09/03/2020
• Decision Date: 10/06/2021
• Product Code: PAA
• Docket Number: 21M-1352
• Notice Date: 12/23/2021
• Advisory Committee: Radiology
• Clinical Trials: NCT03257839
• Expedited Review Granted?: No
• Combination Product: No

Approval Order 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 be used at the same visit as screening mammography and SoftVue images are intended to be interpreted with the mammogram results to enhance screening.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001