PMA
P990066: GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA PMA · Full field digital, system, x-ray, mammographic · GE Healthcare
Key facts
| PMA number | P990066 |
|---|---|
| Trade name | GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
| Generic name | Full field digital, system, x-ray, mammographic |
| Applicant | GE Healthcare |
| Owner/operator | GE HealthCare Technologies Inc. |
| Product code | MUE |
| Approval date | Jan 28, 2000 |
| Docket number | 00M-0579 |
| Notice date | Feb 16, 2000 |
| Establishment registration | 2126677 |
| FEI number | 2126677 |
At a glance
- 10–99 Supplements
- Nov 5, 2010 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: