PMA
P050014: FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)
FDA PMA · Full field digital, system, x-ray, mammographic · Fujifilm Medical System U.S.A., Inc.
Key facts
| PMA number | P050014 |
|---|---|
| Trade name | FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS) |
| Generic name | Full field digital, system, x-ray, mammographic |
| Applicant | Fujifilm Medical System U.S.A., Inc. |
| Owner/operator | FUJIFILM CORPORATION |
| Product code | MUE |
| Approval date | Jul 10, 2006 |
| Docket number | 06M-0295 |
| Notice date | Jul 25, 2006 |
| Establishment registration | 3001722928 |
| FEI number | 3001722928 |
At a glance
- 1–9 Supplements
- Aug 11, 2009 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- No Withdrawn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: