4 devices · 2 companies · 2018 to 2025
Bonraybio Co., LTD.: AI-enabled devices on FDA's list
4 devices from Bonraybio Co., LTD., 2018 to 2025, from 2 companies across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 4 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| LensHooke X3 PRO Semen Quality AnalyzerK242830 · 510(k) | Hematology | POV | database entry | |
| LensHooke X12 PRO Semen Analysis SystemK242388 · 510(k) | Hematology | POV | database entry | |
| LensHooke X1 PRO Semen Quality Analyzer, LensHooK202089 · 510(k) | Hematology | POV | database entry | |
| LensHooke X1 Pro Semen Quality Analyzer, LensHooK180343 · 510(k) | Hematology | POV | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.