ECHELON Synergy MRI system is an AI-enabled medical device from FUJIFILM Healthcare Corporation, listed by FDA (510(k), K223426) with a decision date of 2023-07-13. Review panel: Radiology.
| FDA submission number | K223426 |
|---|---|
| Pathway | 510(k) |
| Company | FUJIFILM Healthcare Corporation |
| Review panel (specialty) | Radiology |
| FDA decision date | 2023-07-13 |
| Decision | Substantially Equivalent |
| Product code | LNH |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Device class | 2 |
| Regulation number | 892.1000 |
| Review time (calendar days) | 241 |
| Applicant country | JP |
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.