LensHooke X12 PRO Semen Analysis System is an AI-enabled medical device from Bonraybio Co., LTD., listed by FDA (510(k), K242388) with a decision date of 2025-05-09. Review panel: Hematology.
| FDA submission number | K242388 |
|---|---|
| Pathway | 510(k) |
| Company | Bonraybio Co., LTD. |
| Review panel (specialty) | Hematology |
| FDA decision date | 2025-05-09 |
| Decision | Substantially Equivalent |
| Product code | POV |
| Classification | Semen Analysis Device |
| Device class | 2 |
| Regulation number | 864.5220 |
| Review time (calendar days) | 270 |
| Applicant country | TW |
Official FDA database record · FDA AI-enabled device list
More devices from Bonraybio Co., 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.