HYDROS Robotic System

JSON twin: https://www.healthaidb.com/software/hydros-robotic-system.json

Company Name

PROCEPT BioRobotics

Product URL

https://www.procept-biorobotics.com/hydros/

Company URL

https://www.procept-biorobotics.com

Categories

• clinical Care
• diagnostic Support
• surgical Care
• robotics
• Clinical
• Diagnostic
• Surgical
• Robotic
• Urology

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.

Api Available

unknown

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

Company Founding

2013

Company Offices

• United States

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

Customers

Data Residency

US-only

Data Standards

• DICOM

Deployment Model

• on_prem

Features

• AI-Powered Treatment Planning
• Advanced Image Guidance
• Robotic Resection
• Streamlined Workflow

Id

SW0178

Integration Partners

Integrations

• Ultrasound Imaging
• Digital Cystoscopy
• High-Definition Touchscreens

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

Os Platforms

• Windows
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

enterprise_quote

Privacy Features

• Data Anonymization
• Data Minimization

Product Code

SW0178

Product Name

HYDROS Robotic System

Ratings

Regions Available

• United States

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Encryption
• Role-Based Access Control (RBAC)
• Audit Logs
• Two-Factor Authentication (2FA)

Specialties

• Urology

Support Channels

System Requirements

Windows, Linux

Target Users

• clinicians
• surgeons
• patients

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "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"
  }
}