SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly

FDA Premarket Approval P200040

Pre-market Approval Supplement Details

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.

DeviceSoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly
Generic NameAutomated Breast Ultrasound
ApplicantDelphinus Medical Technologies
Date Received2020-09-03
Decision Date2021-10-06
PMAP200040
SupplementS
Product CodePAA 
Advisory CommitteeRadiology
Expedited ReviewNo
Combination Product No
Applicant Address Delphinus Medical Technologies 45525 Grand River Avenue novi, MI 48374

Supplemental Filings

A PHP Error was encountered

Severity: Notice

Message: Undefined offset: 0

Filename: fda.report/pma_item.php

Line Number: 133

Backtrace:

File: /var/www/fda.report/pma_item.php
Line: 133
Function: _error_handler

Supplement NumberDateSupplement Type
P200040Original Filing

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.