AI100 with Shonit is an AI-enabled medical device from SigTuple Technologies Pvt. Ltd., listed by FDA (510(k), K221309) with a decision date of 2023-09-19. Review panel: Hematology.
| FDA submission number | K221309 |
|---|---|
| Pathway | 510(k) |
| Company | SigTuple Technologies Pvt. Ltd. |
| Review panel (specialty) | Hematology |
| FDA decision date | 2023-09-19 |
| Decision | Substantially Equivalent |
| Product code | JOY |
| Classification | Device, Automated Cell-Locating |
| Device class | 2 |
| Regulation number | 864.5260 |
| Review time (calendar days) | 502 |
| Applicant country | IN |
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.