DR 800 with MUSICA Dynamic is an AI-enabled medical device from Agfa HealthCare N.V., listed by FDA (510(k), K180589) with a decision date of 2018-04-05. Review panel: Radiology.
| FDA submission number | K180589 |
|---|---|
| Pathway | 510(k) |
| Company | Agfa HealthCare N.V. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2018-04-05 |
| Decision | Substantially Equivalent |
| Product code | JAA |
| Classification | System, X-Ray, Fluoroscopic, Image-Intensified |
| Device class | 2 |
| Regulation number | 892.1650 |
| Review time (calendar days) | 30 |
| Applicant country | BE |
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.