OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System is an AI-enabled medical device from Abbott Medical, listed by FDA (510(k), K210458) with a decision date of 2021-06-08. Review panel: Radiology.
| FDA submission number | K210458 |
|---|---|
| Pathway | 510(k) |
| Company | Abbott Medical |
| Review panel (specialty) | Radiology |
| FDA decision date | 2021-06-08 |
| Decision | Substantially Equivalent |
| Product code | NQQ |
| Classification | System, Imaging, Optical Coherence Tomography (Oct) |
| Device class | 2 |
| Regulation number | 892.1560 |
| Review time (calendar days) | 112 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from Abbott Medical · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.