PMA
P010025: LORAD DIGITAL BREAST IMAGER
FDA PMA · Full field digital, system, x-ray, mammographic · Hologic, Inc.
Key facts
| PMA number | P010025 |
|---|---|
| Trade name | LORAD DIGITAL BREAST IMAGER |
| Generic name | Full field digital, system, x-ray, mammographic |
| Applicant | Hologic, Inc. |
| Owner/operator | HOLOGIC, INC. |
| Product code | MUE |
| Approval date | Mar 15, 2002 |
| Docket number | 02M-0173 |
| Notice date | Apr 25, 2002 |
| Establishment registration | 1222780 |
| FEI number | 1000120743 |
At a glance
- 10–99 Supplements
- Nov 16, 2010 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: