• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
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.
DeviceSoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly
Generic NameAutomated breast ultrasound
ApplicantDelphinus Medical Technologies
45525 Grand River Avenue
Novi, MI 48374
PMA NumberP200040
Date Received09/03/2020
Decision Date10/06/2021
Product Code PAA 
Docket Number 21M-1352
Notice Date 12/23/2021
Advisory Committee Radiology
Clinical TrialsNCT03257839
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001