uOmnispace.CT

by Shanghai United Imaging Healthcare Co., Ltd.  · Based in China →Redefining diagnostic imaging through the power of AI for faster, clearer, and more accurate results.
Cardiology Dentistry Radiology

Regulatory Status Disclosed

Overview

uOmnispace.CT is a specialized component of Shanghai United Imaging Healthcare Co., Ltd.’s comprehensive uOmnispace medical imaging software platform. It is engineered for advanced post-processing, viewing, manipulation, evaluation, and analysis of Computed Tomography (CT) images. The software seamlessly integrates artificial intelligence (AI) and machine learning algorithms to enhance various functions, including automated segmentation, lesion detection, and quantitative analysis. This integration aims to significantly improve diagnostic confidence, streamline workflow efficiency, and bolster clinical decision support for medical professionals. uOmnispace.CT supports DICOM images and can function as a standalone device or integrate with other cleared software options, providing a robust and adaptable solution for healthcare institutions.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • 2D and 3D image viewing and manipulation
  • Annotation and measurement tools
  • Manual and automatic segmentation tools, including AI-based rib extraction
  • DICOM image support and compatibility with various imaging modalities (CT, MRI, PET)
  • Specialized applications for cardiovascular analysis (e.g., vascular stenosis, plaque, heart function, TAVR planning)
  • Specialized applications for dental analysis (e.g., panoramic and paraxial jaw views)
  • Specialized applications for colon evaluation
  • Remote access for multiple users on a network
  • Integration with imaging and hospital information systems via DICOM3.0 standard
  • AI-driven analysis for lesion detection and anatomical segmentation

Use Cases

  • Diagnostic imaging and interpretation for CT scans
  • Pre-operative planning, particularly for cardiovascular procedures like TAVR
  • Quantitative analysis of vascular and cardiac structures
  • Evaluation of bone lesions, fractures, abdominal injuries, and soft tissue injuries
  • Enhancing workflow efficiency and clinical decision support in radiology
  • Support for various clinical workflows in oncology, neurology, and cardiology

What Physicians Need to Know

DICOM Support & Standards
Supports DICOM 3.0 standard and DICOM formatted images and objects, enabling effective communication with various imaging and hospital information systems.
PACS Integration Method
Communicates with imaging systems and medical information systems via DICOM 3.0. It can be used as a stand-alone device or integrated with other cleared software options, allowing remote multi-user access to clinical applications on a network.
Reading Room Workflow Impact
Provides AI-driven analysis tools for lung nodule detection, brain perfusion, cardiovascular and liver evaluations, spine and rib labeling, and TAVR analysis, supporting efficient clinical interpretation, visualization, and quantitative assessment. It offers 2D/3D viewing, annotation, measurement, and segmentation tools to streamline diagnostic workflows.
AI Model Architecture (deep learning approach)
Based on the uOmnispace platform, it incorporates AI-based algorithms, specifically deep learning for segmentation, labeling (e.g., spine and rib), and quantitative analysis of multiple organs and pathologies.
Processing Speed (per study)
Specific 'per study' processing speed data is not explicitly detailed in the provided information.
FDA Clearance Pathway (510k/De Novo)
Received FDA 510(k) clearance (K233209) on May 17, 2024, as a comprehensive medical image management and processing software mainly for CT images.
Supported Modalities (CT/MRI/X-ray/US)
Primarily designed for CT images, uOmnispace.CT leverages a platform that generally supports multimodality DICOM images including CT, MRI, PET, and DR (X-ray).
Sensitivity & Specificity Data
Performance testing included software verification and validation with clinical data, demonstrating high accuracy and generalizability for AI algorithms like spine labeling, rib labeling, and TAVR analysis. For ML-based rib segmentation, an average Dice coefficient of 0.855 was reported, exceeding the 0.8 acceptance criterion. Deep learning-based spine labeling showed a mean identification rate greater than 92%, and rib labeling greater than 91.7%.
RSNA/ACR Validation
No explicit RSNA or ACR validation data was found for uOmnispace.CT in the provided search results, though United Imaging showcases innovations at RSNA.
Physician Tip

uOmnispace.CT offers a robust suite of AI-powered tools for CT image analysis, enhancing diagnostic efficiency and quantitative assessment across various pathologies. Leverage its deep learning-based segmentation and labeling features for improved accuracy in areas like lung nodule detection, brain perfusion, and cardiovascular evaluations. The 2D/3D visualization and advanced analysis capabilities can significantly aid in treatment planning and follow-up. While the system shows high accuracy in its algorithms, always integrate AI insights with comprehensive clinical judgment.

uOmnispace.CT is built to integrate seamlessly into existing radiology ecosystems, supporting the DICOM 3.0 standard for image and information exchange. It can function as a standalone workstation or integrate with PACS and other hospital information systems, facilitating remote multi-user access. This flexibility ensures compatibility with diverse IT infrastructures, minimizing disruption during deployment.

Details

Category Radiology & Imaging AI
Pricing Unknown Unknown
DeploymentSoftware-only medical device, runs on standard off-the-shelf PCs that meet minimum specifications, allows multiple users to access clinical applications on a network remotely.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The uOmnispace platform received 510(k) Premarket Notification on July 20, 2023 (K230039). uOmnispace.CT, a post-processing software based on this platform, had a 510(k) submission dated May 16, 2024. Another FDA clearance for uOmnispace was on December 20, 2023, under 510(k) number K233176.

Integrations
EHR Not specified
Specialties Cardiology, Dentistry, Radiology

What the Web Says

uOmnispace.CT is a medical image post-processing software by United Imaging, designed for viewing, manipulating, evaluating, and analyzing medical images from various modalities like CT, MRI, and PET. It offers advanced features such as AI-enhanced segmentation, 2D/3D viewing, and multi-modality analysis. While some users praise its speed and intuitive interface, concerns exist regarding data security and pricing transparency.

Overall: Mixed

Strengths

  • Blazing fast scanner (for PET/CT, implying potential speed in CT applications).
  • Intuitive Windows-based operating system.
  • Fantastic and responsive tech support.
  • Offers innovative AI-enhanced segmentation and multi-modality analysis.
  • Supports DICOM images and is compatible with CT, MRI, and PET.
  • Can be used as a standalone device or integrated with other software options.

Limitations

  • Lack of transparent pricing, only available upon contact.
  • Concerns about data security due to the company's Chinese origin (raised in Reddit discussions).
  • Some sales representatives are perceived as awkward.
  • Not intended for displaying digital mammography images for diagnosis in the U.S.
  • One Reddit user reported a United Imaging general X-ray machine to be unsatisfactory.
  • Potential for technical/engineering support to decline if the company grows too quickly.

Based on reviews from: HealthAidb, Physician Ai Tools, Reddit (r/Radiology), Medical News Observer, accessdata.fda.gov

Last updated: 2026-07-19

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Videos

Product demos, reviews, and walkthroughs for uOmnispace.CT.

View all on YouTube

Frequently Asked Questions

uOmnispace.CT is a post-processing software that supports DICOM images and can be used as a standalone device or integrated with existing imaging and hospital information systems via DICOM3.0. It allows multiple users to remotely access clinical applications on a network, streamlining image viewing, manipulation, evaluation, and analysis.
uOmnispace.CT provides AI-driven algorithms for segmentation, labeling, and quantitative analysis of various organs and pathologies in CT images. This includes tools for lung nodule detection, brain perfusion analysis, cardiovascular and liver evaluations, as well as spine and rib labeling.
Yes, uOmnispace.CT has received FDA 510(k) clearance in the U.S., with the specific clearance for uOmnispace.CT occurring on May 17, 2024. The broader uOmnispace platform also received 510(k) clearance on July 20, 2023.
While specific details on HIPAA/GDPR compliance are not explicitly detailed in the provided search results, as an FDA-cleared medical device, uOmnispace.CT is subject to stringent regulatory requirements including those related to data handling and security. It supports DICOM standards, which facilitate secure image communication within healthcare institutions.
uOmnispace.CT offers a comprehensive suite of AI-driven analysis tools for multiple organs and pathologies, including advanced visualization and multi-energy CT analysis. Its integration capabilities with various imaging modalities and hospital systems, along with its focus on high accuracy and generalizability, are key strengths.
Specific pricing models for uOmnispace.CT are not publicly disclosed in the provided search results. Typically, AI healthcare solutions may offer subscription-based licenses, per-study fees, or enterprise-wide agreements, and it is recommended to contact United Imaging Healthcare directly for detailed pricing information.
While performance testing showed high accuracy and generalizability across diverse patient subgroups, like all AI, uOmnispace.CT's algorithms are trained on specific datasets and may have limitations in unusual or rare cases not well-represented in training data. It is also explicitly stated that the software is not intended for displaying digital mammography images for diagnosis in the U.S.

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Medical Image Post-processing Software (uOmnispace.CT)
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Radiology & Imaging AI
uOmnispace.CT is an advanced medical image post-processing software by Shanghai United Imaging Healthcare Co., offering 2D/3D viewing, annotation, and AI-enhanced segmentation tools for CT, MRI, and PET images, designed for comprehensive analysis and reporting in healthcare institutions.

View company profile →

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