Eclipse II with Smart Noise Cancellation is an AI-enabled medical device from Carestream Health, Inc., listed by FDA (510(k), K213307) with a decision date of 2022-01-14. Review panel: Radiology.
| FDA submission number | K213307 |
|---|---|
| Pathway | 510(k) |
| Company | Carestream Health, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2022-01-14 |
| Decision | Substantially Equivalent |
| Product code | MQB |
| Classification | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Device class | 2 |
| Regulation number | 892.1680 |
| Review time (calendar days) | 102 |
| Applicant country | US |
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.