Intelligent NR is an AI-enabled medical device from Canon, Inc., listed by FDA (510(k), K252503) with a decision date of 2026-04-30. Review panel: Radiology.
| FDA submission number | K252503 |
|---|---|
| Pathway | 510(k) |
| Company | Canon, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2026-04-30 |
| Decision | Substantially Equivalent |
| Product code | OWB |
| Classification | Interventional Fluoroscopic X-Ray System |
| Device class | 2 |
| Regulation number | 892.1650 |
| Review time (calendar days) | 265 |
| 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.