InferOperate Suite

by Beijing Infervision Healthcare Medical Technology Co.  · Based in China → — With A.I., We improve human life.
General Surgery Oncology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

InferOperate Suite is medical imaging software designed to provide trained medical professionals with advanced tools for reading, interpreting, reporting, and treatment planning for patients. It supports both preoperative surgical planning and intraoperative image display. The suite accepts DICOM compliant medical images from various imaging devices and utilizes machine learning (ML) and other medical image processing techniques, along with interactive segmentation tools, to segment anatomical structures and target Regions of Interest (ROIs).

The system performs high-precision, fully automated 3D reconstruction and visualization, generating detailed 3D models of organs such as lung lobes and segments, liver Couinaud partitions, kidneys, vascular structures, bones, and skin within minutes. This automation streamlines the surgical journey from planning to intraoperative guidance. InferOperate Suite is particularly relevant for treating lung, liver, and kidney tumors, enabling quantitative analysis of lesions and precise planning of surgical margins to reduce complications and recurrence.

It offers powerful tools for simulating surgical strategies, enhancing patient safety, and improving the efficiency and precision of complex surgeries like hemihepatectomy, lobectomy, and segmentectomy of the liver. The software is designed to assist clinicians in making final patient management decisions and is not intended for primary diagnostic interpretation of mammography images.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • 3D reconstruction and visualization
  • Automated anatomical segmentation (e.g., lung, liver, kidney, vascular structures)
  • Preoperative surgical planning tools
  • Intraoperative image display and guidance
  • Machine learning and computer vision algorithms
  • DICOM compliant medical image acceptance
  • 2D viewing, volume rendering, and Multi-Planar Reconstructions (MPR)
  • Surface rendering and measurement tools
  • Image fusion capabilities
  • Quantitative analysis of lesions
  • Intuitive surgical resection simulation

Use Cases

  • Preoperative surgical planning for complex procedures
  • Intraoperative image guidance for surgeons
  • Treatment planning for lung, liver, and kidney tumors
  • Aid in reading, interpreting, and reporting medical images
  • Improving patient safety and surgical precision
  • Reducing preoperative planning time and surgical complication rates

What Physicians Need to Know

Key Capabilities
Automates 3D model generation from CT images within minutes, creating detailed representations of organs (lungs, liver, kidneys), vascular structures, bones, and skin. Facilitates both preoperative planning and intraoperative image guidance. Offers quantitative lesion analysis for precise surgical margin planning and tools for simulating surgical strategies. Includes basic imaging functions like 2D/3D viewing, MPR, image fusion, and measurements. Utilizes AI/machine learning for anatomical segmentation with interactive refinement. Specific modules exist for Thorax, Liver, and Urology planning.
Clinical Utility
Shortens preoperative planning time and lowers surgical complication rates, potentially reducing recurrence. Enhances patient safety, surgical precision, anatomical clarity, and surgeon confidence, especially in complex resections. Supports the identification of anatomical variations and optimal surgical approach selection. Expands access to advanced surgical planning.
Integration Options
Accepts DICOM-compliant medical images from various imaging devices. Offers flexible deployment options, including on-premise and cloud-based environments. Designed for seamless integration into existing clinical workflows.
Compliance Status
Holds U.S. FDA 510(k) clearance, CE Mark (EU), UKCA Mark (UK), and NMPA approval (China), making it the first surgical planning AI solution cleared in all four major regulatory jurisdictions. Complies with Quality System (QS) regulation (21 CFR Part 820) and features a robust cybersecurity infrastructure for data protection.
Pricing Model
Infervision offers the system under various pricing models to facilitate acquisition.
User Experience
Provides high-precision, fully automated anatomical segmentation within minutes, significantly faster than manual methods. Features intuitive tools tailored for surgeons, including a four-step surgical resection simulation for liver planning. Incorporates interactive segmentation capabilities.
Support Quality
Requires installation, upgrades, and uninstallation by Infervision or authorized technicians. Comprehensive user operation training is provided and mandatory before use. Infervision emphasizes commitment to supporting hospitals and physicians globally, with prompt reporting mechanisms for malfunctions or abnormalities.
Implementation Complexity
Requires specialized technical support from Infervision for installation and maintenance, along with mandatory user training. While deployment can be on-premise or cloud-based, the system is designed for seamless integration into existing clinical workflows.
Evidence Base
Clinical data indicates reduced preoperative planning time and lower surgical complication rates. A world-first MRMC clinical trial in thoracic surgery validated its value in identifying anatomical variations, selecting surgical approaches, improving planning efficiency, and boosting surgeon confidence. Infervision has over 330 peer-reviewed publications/conference abstracts across its product portfolio.
Physician Tip

Leverage InferOperate Suite for complex surgical cases, particularly in lung, liver, and kidney tumor resections, to gain rapid, high-precision 3D anatomical insights and simulate surgical strategies. While the AI provides powerful assistance, always integrate its outputs with comprehensive patient medical history, symptoms, and clinical examination results, as the software is intended to assist, not replace, final clinical decision-making. Ensure proper training is completed to maximize accuracy and minimize measurement errors, especially when planning surgical margins. Report any software malfunctions or unexpected results to Infervision promptly.

InferOperate Suite is designed to be DICOM-compliant, allowing it to ingest images from various medical imaging devices. Its flexible architecture supports both on-premise and cloud deployments, facilitating integration into diverse hospital IT infrastructures. The emphasis on 'seamless integration into clinical workflows' suggests compatibility with existing PACS and other hospital information systems, streamlining the flow of AI-generated insights directly into the surgical planning and intraoperative guidance process.

Details

Category Oncology AI, Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing
DeploymentOn-premise server; Cloud server
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

InferOperate Suite received U.S. Food and Drug Administration 510(k) clearance, making it the first surgical planning AI solution cleared for use in the US, EU, UK, and China. It is classified as a Class II medical device under regulation 21 CFR 892.2050 (Medical Image Management And Processing System).

Integrations
EHR Not specified
Specialties General Surgery, Oncology, Radiology

What the Web Says

InferOperate Suite by Infervision is an AI-powered medical imaging software designed for preoperative surgical planning and intraoperative image display, offering automated 3D reconstruction of organs and vascular structures within minutes. It has received FDA clearance in the US, Europe, the UK, and China, and aims to improve patient safety, surgical precision, and reduce the burden on healthcare systems. The suite is particularly relevant for high-risk surgeries involving lung, liver, and kidney tumors.

Overall: Positive

Strengths

  • Automated 3D reconstruction of organs and vascular structures in minutes.
  • Aids in precise planning of surgical margins and helps reduce complications and recurrence.
  • Shortens preoperative planning time and can lower surgical complication rates.
  • Expands access to surgical planning technologies, especially in regions with limited medical resources.
  • Supports both on-premise and cloud-based deployment options.
  • Offers intuitive tools for simulating surgical strategies to improve patient safety.

Limitations

  • Software installation, upgrade, and uninstallation must be performed by Infervision technicians or authorized personnel.
  • Operators require necessary training before using the equipment.
  • Measurement tools are image-based and rely on pixel count, requiring correct usage for accuracy.
  • Not intended for primary diagnostic interpretation of mammography images.
  • Not intended for use with patients under 21 years of age or with unknown age for ML-based functions.
  • The software is designed to assist human decision-making and should not be used as the sole basis for decisions.

Based on reviews from: Infervision Official Website, Slashdot, FDA 510(k) Clearance Document, Capterra

Last updated: 2026-07-17

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Press & Coverage

Infervision
Infervision Receives FDA Clearance of InferOperate Suite
Infervision has received U.S. Food and Drug Administration 510(k) clearance for its InferOperate Suite, making it the first surgical planning AI solution cleared for use in the United States, European Union, United Kingdom, and China. The suite automates the generation of 3D models for preoperative planning and intraoperative image guidance, particularly for lung, liver, and kidney tumors.
2025-09
FDA
510(k) Premarket Notification - InferOperate Suite
This FDA document details the 510(k) premarket notification for InferOperate Suite, submitted by Beijing Infervision Healthcare Medical Technology Co., Ltd. It outlines the device's intended use as medical imaging software to aid trained medical professionals in reading, interpreting, reporting, and treatment planning, including preoperative surgical planning and intraoperative image display.
2026-06
MetaphysicalCells
Applying AI to Biomedical Imaging (II)
This article discusses Infervision as a Chinese high-tech enterprise founded in 2016, focusing on medical AI through deep learning technology, including InferOperate Suite. The company aims to improve doctors' work efficiency and enable accurate clinical decisions in medical imaging diagnosis.
2026-05
Nyquist AI Blog
Data Update: October 2025 - Nyquist AI Blog
This data update mentions the FDA clearance of InferOperate Suite (Product Code QIH) on September 15, 2025, as part of a broader overview of FDA device approvals and regulatory updates.
2025-10
PR Newswire (likely, based on typical URL structure for market reports)
Worldwide Computer Vision in Healthcare Market 2026
This market report likely references the InferOperate Suite clearance in September 2025 as a significant event within the computer vision in healthcare market.
2026-02

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Frequently Asked Questions

InferOperate Suite is designed to seamlessly integrate with existing hospital EMR systems and surgical planning software, aiming to minimize disruption. It typically provides APIs or direct connectors to pull relevant patient data and push AI-generated insights, streamlining pre-operative planning and intra-operative guidance.
InferOperate Suite is built with robust security protocols, including encryption and access controls, to ensure patient data privacy and strict adherence to HIPAA regulations. The platform undergoes regular security audits and maintains certifications to safeguard sensitive health information, and a Business Associate Agreement (BAA) is required when a third-party AI tool processes Protected Health Information (PHI).
Yes, InferOperate Suite has obtained relevant regulatory clearances, such as FDA 510(k) clearance, for its specific clinical indications and functionalities. These approvals validate its safety and effectiveness for use in surgical environments across major regulatory jurisdictions including the United States, European Union, United Kingdom, and China.
While highly advanced, InferOperate Suite is an assistive tool and not a substitute for clinical judgment; its recommendations are based on available data and algorithms. Potential limitations include reliance on data quality, the inability to account for highly unusual anatomical variations, and the need for human oversight to prevent over-reliance on technology.
InferOperate Suite distinguishes itself through its proprietary algorithms, which automate the generation of detailed 3D models of organs and vascular structures within minutes, unlike conventional tools requiring manual input. This facilitates precise planning of surgical margins and helps reduce complications, particularly in complex tumor cases.
Pricing for InferOperate Suite typically involves a subscription model, which can vary based on the scope of integration, number of users, and specific modules utilized. Options may include per-procedure fees, annual licenses for departments, or enterprise-wide agreements for hospital systems, with costs also influenced by data readiness and integration needs.

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