LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer is an AI-enabled medical device from Bonraybio Co., Ltd., listed by FDA (510(k), K180343) with a decision date of 2018-11-16. Review panel: Hematology.
| FDA submission number | K180343 |
|---|---|
| Pathway | 510(k) |
| Company | Bonraybio Co., Ltd. |
| Review panel (specialty) | Hematology |
| FDA decision date | 2018-11-16 |
| Decision | Substantially Equivalent |
| Product code | POV |
| Classification | Semen Analysis Device |
| Device class | 2 |
| Regulation number | 864.5220 |
| Review time (calendar days) | 282 |
| Applicant country | TW |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.