PMA
P010034: SECOND LOOK (TM)
FDA PMA · Analyzer, medical image · Icad, Inc.
Key facts
| PMA number | P010034 |
|---|---|
| Trade name | SECOND LOOK (TM) |
| Generic name | Analyzer, medical image |
| Applicant | Icad, Inc. |
| Owner/operator | iCAD INC. |
| Product code | MYN |
| Approval date | Jan 31, 2002 |
| Docket number | 01M-0060 |
| Notice date | Feb 7, 2002 |
| Establishment registration | 3026970882 |
| FEI number | 3026970882 |
At a glance
- 1–9 Supplements
- Oct 31, 2003 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- Yes Withdrawn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: