PMA
P030007: KODAK MAMMOGRAPHY CAD ENGINE
FDA PMA · Analyzer, medical image · Carestream Health, Inc.
Key facts
| PMA number | P030007 |
|---|---|
| Trade name | KODAK MAMMOGRAPHY CAD ENGINE |
| Generic name | Analyzer, medical image |
| Applicant | Carestream Health, Inc. |
| Owner/operator | Carestream Health, Inc. |
| Product code | MYN |
| Approval date | Nov 23, 2004 |
| Docket number | 05M-0087 |
| Notice date | Mar 9, 2005 |
| Establishment registration | 1317307 |
| FEI number | 1317307 |
At a glance
- 1–9 Supplements
- Mar 23, 2007 Latest supplement decision
- Yes Withdrawn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: