Company profile

Bonraybio Co., LTD.

Bonraybio Co., LTD. has 4 AI-enabled medical devices on the FDA list. The first decision was on November 16, 2018 and the most recent on May 30, 2025 (LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer). Its most common review panel is Hematology (4 devices).

4AI devices

2018First decision

2025Latest decision

1Specialties

Per year

201820202025

Bonraybio Co., LTD. AI devices per year: 2018 1, 2020 1, 2025 2

By specialty

Hematology4

Related guides

Top hematology devices

Timeline

May 30, 2025 · 510(k) K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer · Hematology · POV
May 9, 2025 · 510(k) K242388LensHooke X12 PRO Semen Analysis System · Hematology · POV
October 28, 2020 · 510(k) K202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer · Hematology · POV
November 16, 2018 · 510(k) K180343LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer · Hematology · POV