LensHooke X3 PRO Semen Quality Analyzer

by Bonraybio Co., Ltd.  · Based in Taiwan → — World leader in sperm Semen Analysis System & Optical Technology, dedicated to high-precision and user-friendly medical instruments.
Laboratory Medicine Obstetrics & Gynecology Urology
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Regulatory Status Disclosed

Overview

The LensHooke X3 PRO Semen Quality Analyzer, developed by Bonraybio Co., Ltd., is an automated, in-vitro diagnostic system designed for rapid and precise human semen analysis. Utilizing optical technology and artificial intelligence, the analyzer evaluates critical sperm parameters, including sperm concentration and total motility, in alignment with the World Health Organization (WHO) guidelines.

The system is built for use by fertility specialists, urologists, and andrologists in clinical laboratories and point-of-care (POC) settings. It streamlines the diagnostic workflow by replacing subjective, manual microscopic assessments with a standardized, automated process. This reduces inter-operator variability and speeds up the delivery of diagnostic results.

Key capabilities of the LensHooke X3 PRO include:

  • A built-in 5-inch touchscreen interface for direct operation and real-time monitoring.
  • High-resolution imaging and video playback functionality to visually verify sperm movement and characteristics.
  • Multiple built-in connectivity options to facilitate seamless data transfer and integration with laboratory information systems.
  • Compatibility with specialized consumables, such as test slides and quality control beads, to maintain testing accuracy and standardization.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Use Cases

  • Male infertility diagnosis and evaluation
  • Use in clinical laboratories
  • Use in point-of-care settings
  • Research purposes
  • Application in IVF clinics and andrology labs
  • Post-vasectomy sterility confirmation (with recommended manual confirmation)

What Physicians Need to Know

LIS/LIMS Integration
Features multiple built-in connectivity options, including HDMI, USB, and Ethernet, facilitating seamless data transfer and integration with laboratory systems. It supports automated data transfer to systems like MedITEX IVF, eliminating manual data entry.
Supported Assay Types
Provides direct and calculated measurements for key semen parameters: sperm concentration (M/mL), total motility (PR+NP, %), progressive motility (%), non-progressive motility (%), immotility (%), sperm morphology (normal forms, %), and pH value.
QC/QA Features
Factory calibrated, requiring no user calibration. It utilizes dedicated quality control materials: LensHooke X QC Beads (for pH and concentration), LensHooke X QC Reticle (for concentration), and LensHooke X QC Video (for motility and morphology), all supplied at three different control levels to ensure accuracy and precision.
Result Interpretation AI
Integrates optical design and image analysis with an artificial intelligence (AI) image processing method to fully automate semen quality analysis. Its machine learning algorithms enhance the identification of sperm with high fertilization potential and provide accurate results by analyzing recorded video footage.
Instrument Interfaces
Equipped with a 5-inch touch screen for intuitive operation and result display. Connectivity options include HDMI for external monitors, USB ports for accessories like barcode scanners, and Ethernet for network connections.
Reference Range Intelligence
Performs semen analysis in compliance with established guidelines, such as the WHO 6th Edition (as seen with the X1 PRO, implying similar adherence for X3 PRO), providing quantitative measurements against these standards.
Turnaround Time Impact
Significantly reduces turnaround time, delivering comprehensive semen analysis results in a rapid 2-5 minutes, enhancing laboratory efficiency.
Physician Tip

The LensHooke X3 PRO offers rapid, AI-assisted, and standardized semen analysis, which can significantly streamline male fertility evaluations. Its automated nature and adherence to WHO guidelines help reduce inter-observer variability inherent in manual methods, leading to more consistent and reliable results. Physicians can leverage the detailed reports and video playback for enhanced patient counseling and treatment planning. The quick turnaround time allows for more efficient clinic workflows and potentially faster diagnostic pathways for patients.

The analyzer's multiple built-in connectivity options (HDMI, USB, Ethernet) are crucial for seamless integration into existing laboratory information systems (LIS/LIMS) and clinic networks. The demonstrated integration with MedITEX IVF highlights its capability for automated data transfer, minimizing manual entry errors and improving overall data management efficiency in fertility clinics.

Details

Category Lab & Diagnostics, OB/GYN AI
Pricing Contact for pricing
DeploymentOn-premise (device-based)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The LensHooke X3 PRO Semen Quality Analyzer (K242830) received U.S. FDA 510(k) clearance on May 30, 2025, as a Class II device under regulation 21 CFR 864.5220 (Automated Differential Cell Counter). It is intended for in-vitro diagnostic use in healthcare professional settings to evaluate male fertility.
Integrations
EHR Not specified
Specialties Laboratory Medicine, Obstetrics & Gynecology, Urology

What the Web Says

The LensHooke X3 PRO Semen Quality Analyzer is an in-vitro diagnostic system designed for human semen analysis in healthcare professional settings to evaluate male fertility. It provides direct and calculated quantitative measurements for sperm concentration, total motility, sperm morphology, and pH value. The device has received FDA clearance and is considered substantially equivalent to previous models, with studies demonstrating user accuracy and ease of use.

Overall: Positive

Strengths

  • Easy to use and precise
  • High resolution and video play function
  • Multiple built-in connectivity options
  • Automated quantitative assessment of semen quality
  • Aids clinical decision-making regarding male fertility status
  • FDA-cleared for in-lab use

Limitations

  • Does not provide a comprehensive evaluation of a male's fertility status
  • Intended for single-person use only and should not be shared (for the SE model, which is a self-testing version)

Based on reviews from: Bonraybio (bonraybio.com), accessdata.fda.gov, FDA.report, Innolitics, ResearchGate

Last updated: 2026-07-17

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Videos

Product demos, reviews, and walkthroughs for LensHooke X3 PRO Semen Quality Analyzer.

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Frequently Asked Questions

The AI-powered system automates the assessment of key semen parameters like concentration, motility, and morphology, reducing human error and providing consistent, objective results. This significantly streamlines the analysis workflow in a clinical setting, allowing for quicker patient turnaround.
The LensHooke X3 PRO Semen Quality Analyzer has received FDA 510(k) clearance, ensuring its safety and efficacy for clinical use. While specific details on HIPAA/GDPR compliance are not explicitly stated in public FDA documents, medical devices typically incorporate robust data encryption and access controls to protect sensitive health information.
The LensHooke X3 PRO integrates optical design and image analysis with artificial intelligence to fully automate semen quality analysis, including pH, concentration, motility, and morphology. It offers high precision, minimizing human error, and provides rapid, comprehensive reports, often surpassing the objectivity and speed of manual methods.
The cost structure typically involves an initial capital expenditure for the analyzer. Ongoing operational costs include proprietary consumables such as disposable semen test cassettes and quality control materials. Maintenance contracts and software updates may also be part of the ongoing operational expenses.
While highly accurate, the AI in the LensHooke X3 PRO may have limitations in interpreting extremely rare morphological abnormalities or highly viscous samples. In such specific scenarios, or if sperm clustering or foreign substances are detected, a manual microscopic verification by an experienced embryologist or physician might be necessary to ensure diagnostic accuracy.
The LensHooke X3 PRO features multiple built-in connectivity options, which typically include capabilities for seamless data transfer. This allows for integration with existing EHR systems, often via standard protocols, to automate the transfer of results and improve overall workflow efficiency.
Manufacturers typically provide comprehensive initial training for laboratory staff on device operation, calibration, and routine maintenance. Ongoing technical support, including troubleshooting and software updates, is usually available through service contracts to ensure continuous optimal performance.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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