PMA
P160009: PowerLook® Tomo Detection Software
FDA PMA · Analyzer, medical image · Icad, Inc.
Key facts
| PMA number | P160009 |
|---|---|
| Trade name | PowerLook® Tomo Detection Software |
| Generic name | Analyzer, medical image |
| Applicant | Icad, Inc. |
| Owner/operator | iCAD INC. |
| Product code | MYN |
| Approval date | Mar 24, 2017 |
| Docket number | 17M-1950 |
| Notice date | Mar 29, 2017 |
| Establishment registration | 3026970882 |
| FEI number | 3026970882 |
At a glance
- None Supplements
- Mar 24, 2017 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- No Withdrawn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: