Imagio Breast Imaging System is an AI-enabled medical device from Seno Medical Instruments, Inc., listed by FDA (PMA, P200003) with a decision date of 2021-01-11. Review panel: Radiology.
| FDA submission number | P200003 |
|---|---|
| Pathway | PMA |
| Company | Seno Medical Instruments, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2021-01-11 |
| Product code | QNK |
| Classification | Optoacoustic Imaging System |
| Device class | 3 |
| Review time (calendar days) | 346 |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.