uDR Aurora CX

by Shanghai United Imaging Healthcare Co.  · Based in China → — Designed for Freedom
Radiology
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Regulatory Status Disclosed

Overview

The uDR Aurora CX is a cutting-edge Digital Radiography (X-ray) System developed by Shanghai United Imaging Healthcare Co. It is characterized by its ‘Born with AI’ philosophy, integrating advanced artificial intelligence, computer vision, and robotics to revolutionize clinical imaging workflows. The system features two uAI® Vision Cameras embedded in the tube head that create a real-time 3D model of each patient, enabling fully automated patient positioning with a single button push. It automatically configures collimation and exposure settings tailored to the patient’s body habitus, while still allowing for technologist customization. An embedded AI quality control system provides real-time feedback and preventative alerts during the entire X-ray procedure, aiming to reduce repeat exams and minimize patient radiation exposure. Furthermore, its next-generation AI image processing platform delivers improvements in image enhancement, tissue equalization, and multi-scale denoising to support high image quality at low dose. The uDR Aurora CX is intended to acquire X-ray images of various human body parts, providing visual evidence for diagnostic decisions by radiologists and clinicians.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-enabled automated patient positioning with one-button operation
  • uAIu00ae Vision Cameras for real-time 3D patient modeling
  • Automated configuration of collimation and exposure settings
  • Embedded AI quality control system with real-time feedback and preventative alerts
  • AI image processing for tissue equalization and multi-scale denoising
  • Designed to reduce repeat exams and minimize patient radiation exposure
  • Retrospective quality analysis and analytics-driven data for departmental programs
  • Streamlined workflows and enhanced patient comfort
  • uVERA platform providing vision-enabled robotics and AI
  • Supports high image quality at low dose across diverse patient populations

Use Cases

  • General digital radiography and X-ray imaging
  • Acquiring X-ray images of the skull, spinal column, chest, abdomen, extremities, limbs, and trunk
  • Improving diagnostic confidence for radiologists and clinicians
  • Optimizing workflow and efficiency for radiologic technologists
  • Reducing patient examination time in X-ray machines
  • Supporting departmental quality improvement initiatives through data analysis

What Physicians Need to Know

FDA Clearance Pathway
510(k) cleared (K251167) on September 19, 2025.
Supported Modalities
Digital Radiography (X-ray) for general human body imaging (skull, spinal column, chest, abdomen, extremities, limbs, trunk). Not intended for mammography.
AI Model Architecture (deep learning approach)
Utilizes the uVERA platform with two uAI Vision Cameras to create a real-time 3D patient model for automated positioning, collimation, and exposure settings. Features an AI image processing platform for image enhancement, tissue equalization, and multi-scale denoising. The uVision algorithm optimizes workflow through patient positioning recognition, body modeling, and pose estimation.
Reading Room Workflow Impact
Designed to streamline workflows, reduce repeat exams, and minimize patient radiation exposure. Provides real-time image quality feedback and preventative alerts to technologists. Offers retrospective quality analysis for departmental quality programs. Can reduce general exam times by up to 50%, with chest X-rays completed in as little as 30 seconds (including positioning, exposure, acquisition, and post-processing).
Processing Speed (per study)
Capable of completing a chest X-ray exam in as little as 30 seconds, encompassing positioning, exposure, image acquisition, and post-processing. General exam times can be reduced by up to 50%.
DICOM Support & Standards
Generates DICOM-standard images.
PACS Integration Method
As a digital radiography system generating DICOM-standard images, it is expected to integrate with PACS via standard DICOM protocols (e.g., DICOM Store, Query/Retrieve).
RSNA/ACR Validation
The system was showcased at the Radiological Society of North America (RSNA) meeting following its FDA clearance.
Physician Tip

The uDR Aurora CX's AI-driven automation for patient positioning, collimation, and exposure settings can significantly improve image consistency and reduce variability, leading to more reliable diagnostic images. The real-time quality control feedback and retrospective analysis tools can aid in continuous quality improvement initiatives within the radiology department, potentially reducing repeat examinations and optimizing radiation dose. While the AI focuses on acquisition and quality, the resulting high-quality, consistent images can enhance diagnostic confidence for radiologists.

The system's ability to generate DICOM-standard images ensures compatibility with existing PACS and other imaging informatics systems. Facilities should confirm specific DICOM conformance statements with United Imaging to ensure seamless integration with their current infrastructure for image storage, retrieval, and viewing. The embedded AI features operate within the DR system itself, minimizing external integration complexities for AI processing.

Details

Category Radiology & Imaging AI
Pricing Unknown — unknown
DeploymentOn-premise (as a physical medical imaging system)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The uDR Aurora CX received FDA clearance (K251167) on September 19, 2025, as a Class II Digital Medical X-ray Imaging System. It is intended for acquiring two-dimensional X-ray images of the human body for diagnostic decisions, not for mammography.
Integrations
EHR Not specified
Specialties Radiology

Ratings & Reviews

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Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

MVPro Media
United Imaging Unveils Aurora CX with Vision-Enabled Automation
United Imaging launched the uDRu00ae Aurora CX, a digital radiography system that uses AI, computer vision, and robotics to enhance clinical imaging workflows through automated patient positioning and real-time quality control. The system creates a 3D patient model for precise positioning and adjusts imaging parameters to minimize radiation dose and repeat scans.
2025-10
PR Newswire
United Imaging Announces the uDRu00ae Aurora CX
United Imaging announced its new FDA-cleared uDR Aurora CX digital radiography system, which integrates computer vision, automation, and AI diagnostics. The system, featuring the uVERA platform and uAIu00ae Vision Cameras, enables fully automated patient positioning and real-time AI quality control to reduce repeat exams and minimize radiation exposure.
2025-09
Diagnostic Imaging
United Imaging Launches AI-Enabled X-Ray Platform uDR Aurora CX
United Imaging has launched the uDR Aurora CX X-ray platform, emphasizing AI capabilities for automated patient positioning, quality control, and image processing. The system aims to balance image quality with minimizing radiation dose through AI-driven feedback and advanced image processing.
2025-09
Radiology Today
FDA Clears United Imaging's Digital Radiography System with AI-Driven Automation
The FDA has cleared United Imaging's uDR Aurora CX, a digital radiography system that incorporates AI-driven automation for patient positioning, exposure control, and image quality. The system also provides retrospective quality analysis and an AI image processing platform for enhanced image quality at low doses.
2025-09
X-ray Interpreter
uDR Aurora CX | FDA Radiology AI Device
The uDR Aurora CX, developed by Shanghai United Imaging Healthcare Co., Ltd., received FDA approval on September 19, 2025. This stationary X-Ray system is designed for radiology applications, providing high-quality X-Ray images for diagnostic purposes and potentially supporting AI tools in image analysis.
2025-09
openPR.com
Digital Radiography Systems Market is expected to reach US$1.9 Billion by 2029
United Imaging obtained FDA clearance for its uDR Aurora CX digital radiography system on September 29, 2025. This system integrates computer vision, real-time 3D patient modeling, automated patient positioning, and AI-driven exposure/quality control, signifying a move towards automation in intelligent radiography rooms.
2025-12
Signify Research
Landmark Acquisitions, Trials, Regulatory Clearances and Deals Break Headlines in the X-ray Market
United Imaging's FDA-approved uDR Aurora CX, a ceiling-suspended digital radiography system, integrates the uVERA platform with two cameras for AI-based robotics. Key features include one-button auto-positioning, auto-collimation, and automatic exposure settings based on patient morphology, alongside active quality control to reduce retakes.
2025-11
Coherent Market Insights
Medical Digital Imaging System Market Size, Trends & Forecast, 2026-2032
In September 2025, United Imaging launched the AI-enabled uDR Aurora CX X-ray platform, which features automated patient positioning, exposure control, and AI-driven image processing for improved low-dose clarity. The system also includes real-time AI quality control to reduce repeat scans and support technologists.
2026-01

Videos

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Frequently Asked Questions

The uDR Aurora CX integrates AI for automated patient positioning, collimation, and optimal exposure parameter settings, utilizing uAIu00ae Vision Cameras to create a real-time 3D patient model. This automation aims to reduce exam times by up to 50%, minimize repeat exams, and enhance image consistency and quality at low doses, ultimately improving patient comfort and diagnostic confidence.
Yes, the uDR Aurora CX has received FDA 510(k) clearance (K251167) as a Class II medical device. It is intended for acquiring two-dimensional X-ray images of various human body parts, such as the skull, spinal column, chest, and extremities, but it is not intended for mammography.
The system's AI features, including automated positioning and real-time quality control, streamline workflow by reducing manual adjustments and providing immediate feedback to technologists. This leads to fewer repeated exams, more consistent high-quality images across different technologists, and allows staff to focus more on patient care.
While highly automated, physicians should note that the uDR Aurora CX is specifically not intended for mammography applications. As with any AI system, understanding its specific algorithms and potential edge cases, although not detailed in public information, is crucial for comprehensive clinical oversight.
The uDR Aurora CX differentiates itself with its 'Born with AI' strategy, deeply integrating computer vision, robotics, and AI for automated positioning, collimation, and real-time quality control from its core design. While other companies like Philips, GE Healthcare, Carestream, and Fujifilm also offer advanced digital radiography systems, United Imaging emphasizes its native AI integration for enhanced workflow and image consistency.
Specific pricing models for the uDR Aurora CX are not publicly disclosed in the available information and would typically require direct inquiry with United Imaging Healthcare. However, the system is described as coming fully configured with all available software features and applications, including a 'Software Upgrades for Life' program.
While specific details on data privacy and security measures for the AI components are not explicitly outlined in the provided information, as an FDA-cleared medical device, the uDR Aurora CX must comply with stringent regulatory requirements. This typically includes adherence to data protection standards and secure handling of patient information.

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