PowerLook® Tomo Detection Software is an AI-enabled medical device from iCAD Inc, listed by FDA (PMA, P160009) with a decision date of 2017-03-24. Review panel: Radiology.
| FDA submission number | P160009 |
|---|---|
| Pathway | PMA |
| Company | iCAD Inc |
| Review panel (specialty) | Radiology |
| FDA decision date | 2017-03-24 |
| Product code | MYN |
| Classification | Analyzer, Medical Image |
| Device class | 2 |
| Regulation number | 892.2070 |
| Review time (calendar days) | 353 |
Official FDA database record · FDA AI-enabled device list
More devices from iCAD Inc · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.