uAngio AVIVA CX

Cardiology Interventional Radiology Vascular Surgery

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Regulatory Status Disclosed

Overview

The uAngio AVIVA CX is an advanced angiographic X-ray system developed by Shanghai United Imaging Healthcare Co. It integrates artificial intelligence, intelligent voice control (uLingo), 3D vision (uSpace), and sophisticated robotics to revolutionize interventional procedures. The system is designed to provide intelligent, safe, and precise image guidance, enabling clinical staff to maintain focus on the patient through hands-free operation.

Key technological advancements include an 8-axis ceiling-mounted robotic system that offers exceptional flexibility and full lab coverage, allowing transverse movement and easy patient access without moving the table. Its innovative C-arm back-folding design also enhances sterility in the operating environment. The uAngio AVIVA CX utilizes uVERA IQ intelligent imaging technology, powered by proprietary AI algorithms, to deliver high-quality images at low radiation doses across various anatomical regions.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Intelligent Voice-Control System (uLingo)
  • Intelligent Vision (uSpace, 3D model reconstruction)
  • 8-axis Ceiling-Mounted Robotic System
  • uVERA IQ Intelligent Imaging Technology (low dose, high quality)
  • Transverse Movement for full lab coverage
  • C-arm back-folding design for enhanced sterility
  • 270u00b0 Z-rotation for optimal working position
  • Hands-free interaction in clinical scenarios
  • AI algorithms for image processing and system control
  • Software Upgrades for Lifeu2122

Use Cases

  • Cardiac angiography and interventions
  • Neuro-angiography and interventions
  • Oncology procedures
  • Peripheral interventional procedures
  • Vascular and non-vascular angiography
  • Surgical procedures

What Physicians Need to Know

FDA Clearance Pathway
510(k) clearance (K243376) granted for the uAngio AVIVA interventional radiology X-ray system.
Supported Modalities
Interventional X-ray system, designed for interventional radiology, neuro interventions, and interventional cardiology procedures. Capable of imaging pediatric patients and those with metal implants.
AI Model Architecture
Leverages proprietary AI algorithms (uVERA IQ intelligent imaging technology) for high-quality, low-dose imaging. Voice detection is powered by an advanced neural network model, and the uLingo voice control function is based on machine learning.
Reading Room Workflow Impact
Significant impact through intelligent voice-control and 3D vision, enabling hands-free image review and movement assistance. The 8-axis robotic system offers exceptional flexibility and full lab coverage, streamlining workflows and allowing clinical staff to focus on the patient.
RSNA/ACR Validation
Showcased at RSNA 2025 as an FDA-cleared interventional X-ray system, highlighting its intelligent robotics, advanced low-dose imaging, and voice assistant capabilities.
Physician Tip

The uAngio AVIVA CX's intelligent voice-control and 3D vision systems can significantly enhance procedural focus and efficiency by enabling hands-free operation and movement within the interventional suite. This allows for maintaining sterile conditions and direct patient focus during complex procedures. The 8-axis robotics provides unparalleled flexibility for optimal imaging angles and full lab coverage, which is particularly beneficial for challenging cases like EVAR and TAVI. The uVERA IQ imaging technology, powered by AI, aims to deliver high-quality images at low radiation doses, which is crucial for patient and staff safety in interventional settings.

As a modern interventional X-ray system, the uAngio AVIVA CX is expected to integrate with existing hospital imaging infrastructure, likely supporting DICOM standards for image transfer and archiving. While specific PACS integration methods were not detailed, its design for streamlined workflows in interventional suites implies compatibility with standard PACS for image review and management. United Imaging offers 'All-in Configurations' and 'Software Upgrades for Life,' suggesting a comprehensive and future-proof approach to system integration and maintenance.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Contact vendor All-in Configurations™; Software Upgrades for Life™
DeploymentOn-premise
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The uAngio AVIVA CX received FDA clearance (K243376) as an angiographic X-ray system for image guidance in diagnostic, interventional, and surgical procedures, including cardiac, neuro, oncology, and peripheral interventions.

Integrations
EHR Not specified
Specialties Cardiology, Interventional Radiology, Vascular Surgery

What the Web Says

The uAngio AVIVA CX is an intelligent, ceiling-mounted angiography system from United Imaging, designed to assist medical staff during interventional procedures. It features intelligent voice control, 3D vision, robotics, and advanced imaging capabilities, aiming to enhance diagnostic confidence, operational efficiency, and patient safety by providing high-quality images at low radiation doses. The system received FDA clearance in May 2025.

Overall: Positive

Strengths

  • Exceptional image quality at low radiation doses (up to 70% reduction in cine mode, 80% in DSA, and 60% in fluoro mode).
  • Intelligent voice-control system for hands-free operation, allowing staff to focus on the patient.
  • 8-axis ceiling-mounted robotic system offers exceptional flexibility and full coverage of the lab space, enabling easy tableside accessibility and optimizing space usage.
  • Intelligent 3D vision (uSpace) reconstructs a 3D model of the patient and room, enabling autonomous identification of target areas and adjustment of exposure parameters.
  • Supports a wide variety of patient and exam types, including cardiac, neuro, oncology, and peripheral interventional procedures.
  • Innovative C-arm back-folding design enhances sterility by allowing laminar flow to circulate more freely.

Limitations

  • No specific cons were found in the provided search results.
  • No independent physician reviews or opinions from healthcare IT, tech reviewers, Reddit, G2, or Capterra were found in the provided search results.

Based on reviews from: United-Imaging, United Imaging Healthcare, Pienomial, accessdata.fda.gov, FDA Clears New Interventional X-Ray Platform from United Imaging, United Imaging gains FDA clearance for uAngio AVIVA X-ray system, United Imaging showcases sustainable, AI-driven innovations at ECR 2025, China Top Medical Devices List, Premiere at ECR 2025 - uAngio AVIVA - YouTube, uAngio AVIVA: Intelligent Angiography System - YouTube, AI in the Angio Suite: Interventional Radiology's Quiet Frontier

Last updated: 2026-07-20

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Press & Coverage

vertexaisearch.cloud.google.com
Major International Breakthrough for China's Interventional Imaging
United Imaging announced on June 18, 2025, that its self-developed Digital Subtraction Angiography (DSA) system, uAngio AVIVA CX, achieved a major international breakthrough. This system is highlighted as the first domestically produced DSA equipment to enter the US market after receiving FDA 510(k) certification.
2025-06
United Imaging Healthcare
uAngio AVIVA - United Imaging Healthcare
This page introduces the uAngio AVIVA CX as an intelligent ceiling-mounted angiography system with intelligent voice-control, vision, robotics, and imaging capabilities. It emphasizes the system's ability to revolutionize interventional procedures through features like 3D intelligent vision and 8-axis robotics.
unknown
accessdata.fda.gov
K243376 - 510(k) Premarket Notification - FDA
This FDA 510(k) premarket notification details the uAngio AVIVA CX as an angiographic X-ray system designed for intelligent, safe, and precise image guidance in various interventional procedures. It lists the main components and software characteristics, including patient registration, 2D&3D image viewing, and voice control.
2025-04
Kimyo University Hospital
Launch of Endovascular Services: Advanced Treatment with uAngio AVIVA CX - Kimyo University Hospital
Kimyo University Hospital announced the launch of its new endovascular department, equipped with the uAngio AVIVA CX angiography system, on April 24, 2026. This system provides high-precision imaging and real-time control for minimally invasive treatments, offering benefits like reduced pain, lower complications, and faster recovery for patients.
2026-04
Strattner
uAngio AVIVA CX - Strattner
Strattner highlights the uAngio AVIVA CX as a ceiling-mounted angiograph with eight axes of robotics, offering free movement within the operating room. Key benefits include reduced radiation exposure, high-definition images, voice control, and full room coverage for optimized ergonomics and lab efficiency.
unknown
YouTube (Strattner)
uAngio AVIVA CX Angiography System from United Imaging Healthcare - YouTube
This video showcases the uAngio AVIVA CX angiography system, emphasizing its intuitive bionic technology, intelligent voice control, 3D intelligent vision (uSpace), and 8-axis robotic movement. It also mentions the uVera IQ Imaging Technology for high-definition images with reduced radiation and contrast.
2026-07
FDA
TPLC - Total Product Life Cycle - FDA
The FDA's Total Product Life Cycle database entry for K243376 lists the uAngio AVIVA CX from Shanghai United Imaging Healthcare Co., Ltd. This entry provides regulatory information and indicates its classification as an image-intensified fluoroscopic x-ray system.
2026-07
X-ray Interpreter
uAngio AVIVA CX | FDA Radiology AI Device - X-ray Interpreter
This entry from X-ray Interpreter's FDA Radiology AI Device database provides a brief overview of the uAngio AVIVA CX, noting its predicate devices and device timeline. It confirms the device is from Shanghai United Imaging Healthcare Co., Ltd.
2025-04

Videos

Product demos, reviews, and walkthroughs for uAngio AVIVA CX.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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