PMA
P110006: SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)
FDA PMA · Automated breast ultrasound · GE Healthcare
Key facts
| PMA number | P110006 |
|---|---|
| Trade name | SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM) |
| Generic name | Automated breast ultrasound |
| Applicant | GE Healthcare |
| Owner/operator | GE HealthCare Technologies Inc. |
| Product code | PAA |
| Approval date | Sep 18, 2012 |
| Docket number | 12M-1011 |
| Notice date | Sep 25, 2012 |
| Establishment registration | 3005860720 |
| FEI number | 3005860720 |
At a glance
- 10–99 Supplements
- Feb 4, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: