{"product_name":"LensHooke X3 PRO","company_name":"Bonraybio","product_url":"https://bonraybio.com/en","company_url":"https://bonraybio.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0005","summary":"LensHooke X3 PRO is an AI-powered semen quality analyzer developed by Bonraybio, designed to provide rapid and precise assessments of sperm parameters to assist fertility specialists in diagnosing and treating infertility issues.","description":"The LensHooke X3 PRO is a fully automated semen analysis system that leverages artificial intelligence to deliver immediate and accurate measurements of critical sperm parameters, including concentration, motility, morphology, pH, and round cell concentration. Its user-friendly interface and quick analysis time of approximately one minute per sample make it a valuable tool for fertility clinics and laboratories aiming to enhance diagnostic efficiency and precision.","categories":["diagnostic Support","clinical Care","laboratory Testing","reproductive Health","Diagnostic","Clinical","Laboratory","Fertility","Reproductive Health"],"market_segment":["enterprise","smb"],"target_users":["clinicians","fertility specialists","laboratory technicians","reproductive health professionals"],"specialties":["Andrology","Reproductive Medicine","Fertility Diagnostics"],"regions_available":["United States","Taiwan","Greece","Hungary","China","France","Germany"],"languages_supported":["English","Chinese","Greek","Hungarian","French","German"],"pricing_model":"enterprise_quote","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["Taiwan","United States","China","France","Germany","Hungary"],"company_founding":"2019","deployment_model":["on_prem"],"os_platforms":["Windows","macOS","Linux"],"features":["Automated semen quality analysis","pH measurement","Sperm concentration quantification","Motility assessment","Morphology evaluation","AI-driven analysis","User-friendly interface","Rapid analysis time"],"optional_modules":[],"integrations":["PACS","LIS","EMR","CRM","ERP","HL7 interfaces","DICOM interfaces","FHIR interfaces","SNOMED CT","ICD-10 coding systems","HL7 v2 messaging","DICOM imaging standards","FHIR data exchange","SNOMED CT terminology","ICD-10 classification","HL7 v3 messaging","DICOM storage","FHIR resources","SNOMED CT concepts","ICD-10 codes"],"data_standards":["HL7 v2","DICOM","FHIR","SNOMED CT","ICD-10"],"api_available":"unknown","system_requirements":"Windows 10 or later, macOS 10.15 or later, Linux kernel 4.4 or later","compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001"],"certifications":["FDA 510(k)","CE/MDR","ONC","ISO 13485","ISO 14971","IEC 62304","IEC 62366","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8","IEC 60601-1-11","IEC 60601-1-12","IEC 60601-1-15","IEC 60601-1-16","IEC 60601-1-17","IEC 60601-1-18","IEC 60601-1-19","IEC 60601-1-20","IEC 60601-1-21"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA","DLP"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"US/EU regions","customers":["Bonraybio Co., Ltd."],"user_reviews":[],"ratings":[],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2025","integration_partners":[],"id":"SW0005","slug":"lenshooke-x3-pro","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/lenshooke-x3-pro.json"}}