uOmnispace.CT

by United Imaging Healthcare  · Based in China → — To Bring Equal Healthcare for All
Cardiology Dentistry Radiology
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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
uOmnispace.CT supports DICOM images and communicates effectively with various imaging and hospital information systems through the DICOM 3.0 standard.
PACS Integration Method
uOmnispace.CT is designed for integration with PACS (Picture Archiving and Communication Systems) and other hospital IT environments.
Reading Room Workflow Impact
The software aims to accelerate workflow by reducing data loading time and streamlining essential steps. It offers intelligent insights and configurable workflows to manage high exam volumes and limited specialist availability, along with user-centered automation to accelerate reading, reporting, and interpretation. Pre-processing runs algorithms in the background, accelerating workflow by reducing data loading time and streamlining steps like coronary vessel recognition.
AI Model Architecture (deep learning approach)
uOmnispace.CT utilizes deep learning-based algorithms for tasks such as spine and rib labeling, with performance validated on large, diverse datasets. It incorporates AI-driven algorithms for precise coronary artery extraction and heart chamber segmentation. United Imaging's technology integrates native AI and intelligent workflows to support data-rich decisions. The platform includes a suite of 10 deep learning algorithms supporting over 60 clinical applications.
Processing Speed (per study)
Pre-processing features can dramatically cut data loading time from minutes to seconds. The system also features lightning-fast data processing, integrated segmentation and lesion classification algorithms, and automated image reconstruction capabilities to make diagnosis consistent and almost instantaneous.
FDA Clearance Pathway (510k/De Novo)
uOmnispace.CT received FDA 510(k) clearance on December 20, 2023, under number K233176. The software is classified under the FDA product code LLZ for radiology devices.
Supported Modalities (CT/MRI/X-ray/US)
uOmnispace is an advanced software platform for viewing, processing, and analyzing medical images from PET, CT, MR, and SPECT scans. Specifically, uOmnispace.CT offers clinical packages for CT, including applications for CT Heart, CT Dynamic, CT Brain Perfusion, CT Lung Nodule, CT Colon Analysis, CT Liver Evaluation, and CT TAVR Evaluation.
Sensitivity & Specificity Data
For coronary artery extraction, uOmnispace.CT's AI-driven algorithm boasts 91.6% accuracy. In a validation study, deep learning-assisted reconstruction successfully segmented 95% of CTO lesions in coronary CT angiography with no need for manual adjustments.
RSNA/ACR Validation
United Imaging showcases its cutting-edge technologies, including AI-empowered CT solutions, at RSNA. The company highlights its AI-empowered cardiac workflow of the uCT 780 at RSNA 2025.
Physician Tip

uOmnispace.CT's AI-driven features, such as automated coronary artery extraction and heart chamber segmentation, can significantly streamline cardiac assessments. The platform's ability to reduce data loading times and offer intelligent insights can help manage high exam volumes and improve reporting efficiency. The deep learning algorithms for spine and rib labeling, validated on diverse datasets, suggest reliable performance for these specific tasks. Consider leveraging the customizable workflows and multi-modality support for a comprehensive approach to patient care in oncology, neurology, and cardiology.

uOmnispace.CT is designed for seamless integration within complex health IT environments, supporting standard interfaces for RIS/PACS/HIS and multi-vendor interoperability. It also integrates with third-party specialized analytics and partner applications to extend quantification and clinical functionality. The software is compatible with various imaging and hospital information systems through the DICOM 3.0 standard. It can also integrate with systems like Epic, Cerner, and billing systems.

Details

Category Radiology & Imaging AI
Pricing Unknown
DeploymentFlexible deployment options: single-modality, multi-modality, departmental or enterprise-wide implementations. It is built for complex health IT environments with standard interfaces and multi-vendor connectivity. The software can be used as a stand-alone device or integrated with multiple cleared and unmodified software options. It allows multiple users to access clinical applications on a network remotely.
Data ExportUnknown
TrainingUnknown
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Cardiology, Dentistry, Radiology

Support & Reliability

Training ProvidedUnknown

What the Web Says

uOmnispace.CT is a medical image post-processing software developed by Shanghai United Imaging Healthcare Co., Ltd. It is an AI-powered visualization workspace that integrates artificial intelligence, advanced rendering, and user-centered automation for anatomy-based analysis and disease-oriented clinical solutions across various modalities. The software is intended for viewing, processing, evaluating, and analyzing PET, CT, MR, and SPECT images, supporting interpretation and evaluation within healthcare institutions. It received FDA clearance on May 17, 2024, under product code QIH.

Overall: Mixed

Strengths

  • AI-powered visualization and analytics for multi-modality clinical interpretation.
  • Intelligent insights and configurable workflows to manage high exam volumes and limited specialist availability.
  • User-centered automation to accelerate reading, reporting, and interpretation.
  • Disease-oriented clinical packages covering specialties such as Cardiology, Neurology, and Oncology.
  • Supports DICOM images and is compatible with various imaging modalities like CT, MRI, and PET.
  • Fast scanning speeds and intuitive Windows-based user interface.

Limitations

  • Some users have reported negative experiences with United Imaging's general X-ray machines, citing poor image quality.
  • Concerns about data security due to the company being Chinese-owned.
  • One Reddit user described a sales representative as awkward and uncomfortable.
  • Not intended to display digital mammography images for diagnosis in the U.S.

Based on reviews from: medicalexpo.com, fda.gov, indeed.com, healthaidb.com, medicalnewsobserver.com, healthcareaiops.com, remoterocketship.com, reddit.com, parikhradiology.com

Last updated: 2026-11-01

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Press & Coverage

XrayInterpreter.com
Medical Image Post-processing Software (uOmnispace.CT) FDA Clearance
Shanghai United Imaging Healthcare Co., Ltd. received FDA 510(k) clearance for its Medical Image Post-processing Software (uOmnispace.CT) on May 14, 2025. This software is designed for viewing, manipulating, evaluating, and analyzing CT medical images across various body regions, utilizing deep learning algorithms for segmentation and dynamic CT perfusion analysis.
2025-05
Medtech Spectrum
FDA Authorizes AI-Enabled Medical Devices in 2025, Including uOmnispace.CT
The FDA authorized over 100 AI-enabled medical devices in 2025, reflecting the growing integration of AI in healthcare. Among these was Shanghai United Imaging's Medical Image Post-processing Software (uOmnispace.CT), cleared on May 14, 2025.
2025-05
MDPI
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting
A December 2025 publication analyzed FDA-authorized machine learning-enabled medical devices in 2024, noting that uOmnispace.CT (K233209) was cleared via the 510(k) pathway for CT imaging visualization and manipulation. The article provides insights into regulatory characteristics and the increasing role of AI in medical devices.
2025-12
united-imaging.com
uOmnispace.CT Dynamic Analysis: Unlocking Time-Resolved Insight for Confident Diagnosis
United Imaging's uOmnispace.CT Dynamic Analysis offers comprehensive evaluation of time-resolved CT images, providing detailed visualization of vascular enhancement across multiple phases. This is particularly valuable for assessing intracranial collateral circulation and detecting vessel occlusions in conditions like acute ischemic stroke.
unknown
united-imaging.com
uOmnispace.CT Brain Perfusion: Make Every Second Count in Brain Care
United Imaging highlights uOmnispace.CT Brain Perfusion as a solution for automated, quantitative analysis in brain care. It provides a fast and intuitive workflow to support confident stroke decisions and tumor evaluation, aligning with AHA guidelines for acute ischemic stroke.
unknown
National Institutes of Health (NIH)
Clinical Value of Dual Low-Dose Upper Extremity CTA for Hemodialysis AVF/AVG with AI-Based Algorithm
A study published in 2026 investigated the clinical value of dual low-dose upper extremity CTA using an AI-based algorithm, specifically artificial intelligence iterative reconstruction (AIIR). The reconstructed datasets were post-processed using uOmnispace.CT for hyper-realistic rendering (HRR) to improve depiction of vascular anatomy.
2026-02
National Institutes of Health (NIH)
Optimal CCTA Reconstruction Phase for Various Heart Rates and Optimized Acquisition Time Window
A study published in October 2025 aimed to determine the optimal CCTA reconstruction phase for various heart rates. After scanning, original data images were reconstructed using uOmnispace.CT with specific filter functions and iterative reconstruction techniques.
2025-10
MedicalExpo
uOmnispace: AI-powered visualization workspace
MedicalExpo features uOmnispace as an AI-powered visualization workspace that unifies artificial intelligence, advanced rendering, and user-centered automation. uOmnispace.CT is highlighted for its CT clinical packages, offering AI-driven visualization and analytics for various medical specialties.
unknown

Videos

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

View all on YouTube

Frequently Asked Questions

uOmnispace.CT is an AI-powered post-processing software designed to help radiologists view, manipulate, evaluate, and analyze CT medical images. It offers specialized applications for various body regions like the lungs, heart, brain, liver, and vascular structures, providing tools for quantitative analysis and characterization to support diagnosis and treatment planning. The platform integrates AI-driven algorithms for tasks such as segmentation and analysis of anatomical structures, aiming to streamline workflows and enhance efficiency.
uOmnispace.CT is classified as a radiology device and has received FDA 510(k) clearance (K233209) on May 17, 2024, under the AI-associated product code QIH. The broader uOmnispace platform, which uOmnispace.CT is part of, also has FDA 510(k) clearance (K233176) as of December 20, 2023. United Imaging emphasizes compliance with standards like HIPAA, HITECH, GDPR, SOC 2, and ISO 27001 for its uOmnispace software.
While AI in radiology offers significant advancements, it's important to integrate AI-generated findings with clinical context and, when necessary, confirmatory imaging to avoid misinterpretations. AI systems are predominantly image-based and may not inherently incorporate procedural or clinical information into diagnostic interpretations. There are also general concerns among physicians about potential skill loss with increased AI reliance and the critical need for data privacy and validation of safety and efficacy.
Several other medical imaging software platforms offer advanced viewing, processing, and analysis capabilities. Some alternatives in the market include Medicai, Ambra Health, Visage Imaging, RamSoft OmegaAI, PaxeraHealth Ultima360, and Sectra PACS. Other notable alternatives include Aidoc, Change Healthcare Platform, Dicom Systems Unifier Platform, INFINITT Cardiology Suite, Acuo VNA, Viz.ai One, and Studycast.
Specific pricing for uOmnispace.CT is not publicly available and typically requires direct inquiry with United Imaging. Generally, pricing for medical imaging software can vary based on factors like deployment (on-premise vs. cloud), features, and the scale of implementation (single department to enterprise). For CT scanners themselves, prices vary significantly based on slice count, software packages, and other specifications, ranging from $120,000 to over $1,800,000 for new systems.

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