SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface Assembly

FDA PMAFDA 510(k)

Class III (US FDA PMA)

PMA P200040510(k) K172256

by Delphinus Medical Technologies

Identity

Trade Name: SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface Assembly FDA PMA
Generic Name: Automated breast ultrasound FDA PMA

Identifiers

PMA Number: P200040 FDA PMA
510(k) Number: K172256 FDA PMA
FDA Product Code: IYO FDA PMA

Classification

Device Class: Class II FDA PMA
Legislation / Framework: 21 CFR Part 892.1560 FDA PMA
Regulation Number: 892.1560 FDA PMA
Advisory Committee: Radiology FDA PMA
FDA Decision: SESE Substantially Equivalent FDA PMA

The SoftVue Automated Whole Breast Ultrasound System is an automated breast ultrasound device designed to assist in breast cancer screening. It is indicated as an adjunct to mammography for asymptomatic women with dense breast parenchyma, specifically those with BI-RADS c or d density classifications.

This system is intended to increase breast cancer detection rates when used alongside screening mammography. It is not a replacement for mammography and is designed to be used during the same visit, with images interpreted in conjunction with mammogram results.

Frequently asked questions

Is the SoftVue system intended to replace screening mammography?

No, the device is not intended to be used as a replacement for screening mammography. It is specifically indicated as an adjunct to mammography to enhance breast cancer detection.

Which patients are candidates for the SoftVue system?

The system is indicated for asymptomatic women with dense breast parenchyma, specifically those who have been confirmed to have a breast density composition of BI-RADS c or d at the time of their screening mammography.

How should SoftVue images be used in a clinical setting?

SoftVue images are intended to be interpreted alongside the results of a screening mammogram to enhance the overall screening process for patients with dense breast tissue.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: [PDF] softvue™ 3d whole breast ultrasound tomography system ..., The Spectrum from Current Dense Breast Cancer Screenings ..., FDA Approves Delphinus 3D Whole Breast Ultrasound System, HaRi · SoftVue™ Automated Whole Breast Ultrasound System with ..., Delphinus Medical Technologies - 2 FDA 510(k) clearances

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K172256	Class III	Active
FDA PMA	United States	FDA_PMA	P200040	Class III	Active

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Manufacturer

Manufacturer: Delphinus Medical Technologies

Sources (2)

FDA PMA P200040 37 fields · synced Sep 18, 2026
FDA 510(k) K172256 1 fields · synced May 18, 2026