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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceSoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly
Generic Nameautomated breast ultrasound
Applicant
Delphinus Medical Technologies
45525 grand river avenue
novi, MI 48374
PMA NumberP200040
Date Received09/03/2020
Decision Date10/06/2021
Product Code PAA 
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.
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