X100 with Full Field Peripheral Blood Smear (PBS) Application is an AI-enabled medical device from Scopio Labs LTD., listed by FDA (510(k), K201301) with a decision date of 2020-10-02. Review panel: Hematology.
| FDA submission number | K201301 |
|---|---|
| Pathway | 510(k) |
| Company | Scopio Labs LTD. |
| Review panel (specialty) | Hematology |
| FDA decision date | 2020-10-02 |
| Decision | Substantially Equivalent |
| Product code | JOY |
| Classification | Device, Automated Cell-Locating |
| Device class | 2 |
| Regulation number | 864.5260 |
| Review time (calendar days) | 140 |
| Applicant country | IL |
Official FDA database record · FDA AI-enabled device list
More devices from Scopio Labs LTD. · All Hematology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.