PAA · Automated Breast Ultrasound
· Class 3
Overview
| Product Code | PAA |
|---|---|
| Device Name | Automated Breast Ultrasound |
| Device Class | Class 3 |
| Review Panel |
Identification
Adjunct to mammography for breast cancer screening and diagnosis.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P200040 | SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface Assembly | Delphinus Medical Technologies | Oct 6, 2021 | APPR |
| P110006 | SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM) | GE Healthcare | Sep 18, 2012 | APPR |
Top Applicants
- Delphinus Medical Technologies — 1 clearance
- GE Healthcare — 1 clearance
