# PAA · Automated Breast Ultrasound

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/RA-misc/PAA

## Overview

- **Product Code:** PAA
- **Device Name:** Automated Breast Ultrasound
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

Adjunct to mammography for breast cancer screening and diagnosis.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P200040](https://fda.innolitics.com/submissions/RA/RA-misc/PAA/P200040.md) | SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly | Delphinus Medical Technologies | Oct 6, 2021 | APPR |
| [P110006](https://fda.innolitics.com/submissions/RA/RA-misc/PAA/P110006.md) | SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM) | GE Healthcare | Sep 18, 2012 | APPR |

## Top Applicants

- Delphinus Medical Technologies — 1 clearance
- GE Healthcare — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/RA/RA-misc/PAA](https://fda.innolitics.com/submissions/RA/RA-misc/PAA)

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