{"product_name":"HYDROS Robotic System","company_name":"PROCEPT BioRobotics","product_url":"https://www.procept-biorobotics.com/hydros/","company_url":"https://www.procept-biorobotics.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0178","summary":"HYDROS Robotic System is an AI-powered platform for Aquablation therapy, offering precise and efficient treatment for benign prostatic hyperplasia (BPH).","description":"HYDROS Robotic System is a next-generation, AI-powered platform developed by PROCEPT BioRobotics for Aquablation therapy, a minimally invasive procedure for treating benign prostatic hyperplasia (BPH). It integrates FirstAssist AI™ for treatment planning, advanced image guidance, robotic resection, and a streamlined workflow to enhance surgical efficiency and patient outcomes. FDA 510(k) clearance was obtained in August 2024, marking a significant advancement in BPH treatment technology.","categories":["clinical Care","diagnostic Support","surgical Care","robotics","Clinical","Diagnostic","Surgical","Robotic","Urology"],"market_segment":["enterprise","consumer"],"target_users":["clinicians","surgeons","patients"],"specialties":["Urology"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"enterprise_quote","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States"],"company_founding":"2013","deployment_model":["on_prem"],"os_platforms":["Windows","Linux"],"features":["AI-Powered Treatment Planning","Advanced Image Guidance","Robotic Resection","Streamlined Workflow"],"optional_modules":[],"integrations":["Ultrasound Imaging","Digital Cystoscopy","High-Definition Touchscreens"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"Windows, Linux","compliance":["FDA 510(k) Clearance","HIPAA","ISO 13485","ISO 14971","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","IEC 60601-1-22","IEC 60601-1-23","IEC 60601-1-24"],"certifications":["FDA 510(k) Clearance","CE Marking","ISO 13485","ISO 14971","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","IEC 60601-1-22","IEC 60601-1-23","IEC 60601-1-24"],"security_features":["Encryption","Role-Based Access Control (RBAC)","Audit Logs","Two-Factor Authentication (2FA)"],"privacy_features":["Data Anonymization","Data Minimization"],"data_residency":"US-only","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0178","slug":"hydros-robotic-system","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/hydros-robotic-system.json"}}