PMA
P080018: KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY
FDA PMA · Full field digital, system, x-ray, mammographic · Carestream Health, Inc.
Key facts
| PMA number | P080018 |
|---|---|
| Trade name | KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY |
| Generic name | Full field digital, system, x-ray, mammographic |
| Applicant | Carestream Health, Inc. |
| Owner/operator | Carestream Health, Inc. |
| Product code | MUE |
| Approval date | Nov 3, 2010 |
| Docket number | 10M-0591 |
| Notice date | Nov 23, 2010 |
| Establishment registration | 1317307 |
| FEI number | 1317307 |
At a glance
- 1–9 Supplements
- Dec 1, 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- No Withdrawn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: