Optellum Virtual Nodule Clinic, Optellum software, Optellum platform is an AI-enabled medical device from Optellum Ltd, listed by FDA (510(k), K202300) with a decision date of 2021-03-05. Review panel: Radiology.
| FDA submission number | K202300 |
|---|---|
| Pathway | 510(k) |
| Company | Optellum Ltd |
| Review panel (specialty) | Radiology |
| FDA decision date | 2021-03-05 |
| Decision | Substantially Equivalent |
| Product code | POK |
| Classification | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Device class | 2 |
| Regulation number | 892.2060 |
| Review time (calendar days) | 204 |
| Applicant country | GB |
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.