uOmnispace

by Shanghai United Imaging Healthcare Co. Ltd.  · Based in China →Advanced AI-Powered Medical Imaging Software for Comprehensive Diagnostics
Nuclear Medicine Oncology Radiology

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Regulatory Status Disclosed

Overview

uOmnispace, developed by Shanghai United Imaging Healthcare Co. Ltd., is a comprehensive medical imaging software solution designed for medical professionals. It offers advanced 2D and 3D viewing, annotation, and segmentation tools, enhanced by machine learning and deep learning technologies, for thorough imaging and reporting. The software supports DICOM images and is compatible with various imaging modalities including CT, MRI, PET, SPECT, and DR. It functions as a software-only medical device, adaptable for standalone use or integration with other cleared software options. uOmnispace allows multiple users to access clinical applications remotely on a network and communicates effectively with various imaging and hospital information systems through the DICOM3.0 standard. It is intended for use within healthcare institutions to assist clinicians and trained medical technicians in viewing, processing, evaluating, and analyzing medical images to aid in timely and accurate diagnoses.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • 2D and 3D viewing, annotation, and measurement tools
  • Manual and automatic segmentation tools (including AI-based rib and spine extraction)
  • Comprehensive film and reports features
  • Supports DICOM images and multiple modalities (CT, MRI, PET, SPECT, DR)
  • Image registration and lesion segmentation
  • Quantitative analysis of medical images
  • Fusion imaging and dynamic PET data analysis
  • Brain scan quantification and cardiac function analysis
  • Remote multi-user access on a network
  • Integration with imaging and hospital information systems via DICOM3.0

Use Cases

  • Post-processing and analysis of medical images for diagnosis
  • Supporting clinical workflows in oncology, neurology, and cardiology
  • Diagnostic imaging and reporting across various modalities
  • Aid clinicians in making timely and accurate diagnoses
  • Vessel analysis, brain perfusion, heart function, lung nodule evaluation, calcium scoring, and liver evaluation from CT/MR/MI data
  • Image manipulation, communication, and storage within healthcare institutions

What Physicians Need to Know

DICOM Support & Standards
uOmnispace supports DICOM images and communicates effectively with various imaging and hospital information systems through the DICOM3.0 standard. It also supports HL7 and FHIR data standards.
PACS Integration Method
The software can be used as a standalone device or integrated with multiple cleared and unmodified software options. It communicates with imaging and hospital information systems via the DICOM3.0 standard. A common integration pattern involves treating the AI system as a DICOM node, where PACS forwards studies to uOmnispace, and AI findings are returned as DICOM Structured Reports (SR) or new image series.
Reading Room Workflow Impact
uOmnispace is designed to assist medical professionals in viewing, processing, evaluating, and analyzing medical images. It offers 2D and 3D viewing, annotation, measurement, and manual/automatic segmentation tools. The AI-powered post-processing aims to drive intelligent insights, precision evaluation, and personalized theranostics with auto segmentation, reading, and reporting, including the ability to generate structured draft reports for radiologists.
AI Model Architecture (deep learning approach)
The software incorporates machine learning technology for features such as rib extraction algorithms and deep learning-based algorithms for spine and rib labeling. United Imaging Intelligence (UII), the AI-focused subsidiary, leverages multimodal foundation models that integrate language, vision, and speech to power AI agents like uAI Insight.
FDA Clearance Pathway (510k/De Novo)
uOmnispace received 510(k) Premarket Notification (K230039) on July 20, 2023. An additional 510(k) clearance (K233176) was granted on December 20, 2023, for uOmnispace.MI.
Supported Modalities (CT/MRI/X-ray/US)
uOmnispace supports DICOM images from various modalities including CT, MRI, PET, and SPECT. Specific applications exist for CT (uOmnispace.CT) and MRI (uOmnispace.MR). It is explicitly stated that the software is not intended to display digital mammography images for diagnosis in the U.S.
RSNA/ACR Validation
United Imaging consistently showcases its AI and imaging technologies at RSNA. At RSNA 2025, United Imaging Intelligence (UII) presented uAI Insight, an AI agent that demonstrated high performance in detecting thoracic and neurological conditions, indicating validation through presentation at major radiological conferences.
Physician Tip

Leverage uOmnispace's advanced 2D/3D viewing, annotation, and AI-powered segmentation tools to enhance diagnostic precision and streamline reporting. Utilize the deep learning algorithms for automated tasks like spine and rib labeling to reduce manual workload. Explore the integration capabilities to seamlessly incorporate AI-generated insights into existing PACS workflows, potentially through DICOM Structured Reports, for a more efficient reading experience. While the platform supports a wide range of modalities, remember its specific limitation regarding digital mammography for diagnosis in the U.S.

uOmnispace is designed for flexible integration, functioning as a standalone device or integrating with existing hospital information systems via DICOM3.0, HL7, and FHIR standards. Its ability to act as a DICOM node allows for efficient routing of studies for AI processing and the return of results directly into the PACS. This architecture supports multi-vendor applications, allowing for a scalable departmental or enterprise solution that adapts to various imaging and hospital information systems.

Details

Category Radiology & Imaging AI
Pricing Contact vendor Contact vendor for details; subscription model mentioned for company's software offerings generally.
DeploymentSaaS, On-premise, Hybrid
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

uOmnispace received 510(k) Premarket Notification (K230039) on July 20, 2023, as a software-only medical device for viewing, manipulation, communication, and storage of medical images, including AI-based segmentation tools.

Integrations
EHR Not specified
Specialties Nuclear Medicine, Oncology, Radiology

What the Web Says

uOmnispace, developed by United Imaging, is a comprehensive medical imaging software solution designed for physicians and trained medical technicians. It offers advanced 2D and 3D viewing, annotation, measurement, and segmentation tools, enhanced by machine learning, for various imaging modalities like CT, MRI, and PET. The software is adaptable, functioning as a standalone device or integrated with other cleared software options, and supports DICOM images and communication with hospital information systems. It received 510(k) Premarket Notification on July 20, 2023, and FDA clearance on December 20, 2023.

Overall: Mixed

Strengths

  • Comprehensive 2D and 3D viewing, annotation, and segmentation tools
  • Enhanced by machine learning for features like rib extraction
  • Compatible with various imaging modalities (CT, MRI, PET, SPECT)
  • Supports DICOM images and communicates with hospital information systems
  • Can be used as a standalone device or integrated with other applications
  • Allows multiple users to remotely access clinical applications on a network

Limitations

  • Not intended for displaying digital mammography images for diagnosis in the U.S.
  • Concerns about potential impact of trade wars and tariffs on parts availability for United Imaging products (general company concern, not specific to uOmnispace)
  • Cybersecurity concerns related to Chinese-developed technology (general company concern, not specific to uOmnispace)
  • CT imaging quality perceived as subpar compared to competitors like GE (general company concern, not specific to uOmnispace)

Based on reviews from: Medical News Observer, HealthAidb, accessdata.fda.gov, Reddit

Last updated: 2026-07-22

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Videos

Product demos, reviews, and walkthroughs for uOmnispace.

View all on YouTube

Frequently Asked Questions

uOmnispace is designed as a hospital-grade intelligent post-processing software suite that integrates with various imaging and hospital information systems using the DICOM 3.0 standard. It offers AI-powered tools for tasks such as image registration, lesion segmentation, quantitative analysis, and deep learning-based algorithms for spine and rib labeling, as well as cardiac ventricular analysis, supporting workflows in oncology, neurology, and cardiology.
uOmnispace has received FDA 510(k) clearance, indicating it is a legally marketed medical device. It is designed to comply with major healthcare regulations including HIPAA, HITECH, GDPR, SOC 2, and ISO 27001, and incorporates security features like end-to-end encryption and role-based access control to protect patient data.
Yes, it is important to note that uOmnispace is not intended for displaying digital mammography images for diagnosis in the U.S. While it supports various modalities like PET, CT, MR, and SPECT, users should consult the specific product documentation for any other limitations or contraindications related to its advanced applications.
uOmnispace distinguishes itself as a comprehensive post-processing platform from United Imaging, offering a wide range of AI-enhanced tools for multi-modality image analysis in oncology, neurology, and cardiology. Its high openness and compatibility allow for flexible integration with third-party vendors and information technology systems, which can be a key differentiator when evaluating against other solutions.
The pricing details for uOmnispace are not publicly disclosed and require direct contact with the vendor, United Imaging. It is offered under a subscription model, and the overall cost implications for a healthcare practice or hospital would depend on factors such as the specific modules required, the scale of deployment, and integration needs.
uOmnispace utilizes deep learning-based algorithms, such as those for spine and rib labeling and cardiac ventricular analysis. Performance validation for these algorithms has been conducted on large, diverse datasets to ensure high accuracy and robustness, with testing demonstrating high consistency compared to predicate devices.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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