PMA
P010017: SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA PMA · Full field digital, system, x-ray, mammographic · Hologic, Inc.
Key facts
| PMA number | P010017 |
|---|---|
| Trade name | SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
| Generic name | Full field digital, system, x-ray, mammographic |
| Applicant | Hologic, Inc. |
| Owner/operator | HOLOGIC, INC. |
| Product code | MUE |
| Approval date | Sep 25, 2001 |
| Docket number | 01M-0509 |
| Establishment registration | 1222780 |
| FEI number | 1000120743 |
At a glance
- 1–9 Supplements
- Feb 13, 2006 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- No Withdrawn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: