Sight OLO is an AI-enabled medical device from Sight Diagnostics Ltd., listed by FDA (510(k), K190898) with a decision date of 2019-11-01. Review panel: Hematology.
| FDA submission number | K190898 |
|---|---|
| Pathway | 510(k) |
| Company | Sight Diagnostics Ltd. |
| Review panel (specialty) | Hematology |
| FDA decision date | 2019-11-01 |
| Decision | Substantially Equivalent |
| Product code | GKZ |
| Classification | Counter, Differential Cell |
| Device class | 2 |
| Regulation number | 864.5220 |
| Review time (calendar days) | 210 |
| Applicant country | IL |
Official FDA database record · FDA AI-enabled device list
All Hematology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.