uOmnispace.MI

by United Imaging Healthcare (uOmnispace.MI)  · Based in China → — To Bring Equal Healthcare for All
Nuclear Medicine Oncology Radiology

Overview

uOmnispace.MI, developed by Shanghai United Imaging Healthcare Co., Ltd., is a comprehensive medical imaging software solution designed for medical professionals. It functions as a hospital-grade intelligent post-processing software suite, assisting healthcare professionals in viewing, processing, evaluating, and analyzing medical images from various modalities, including PET, CT, MR, and SPECT scans. [12, 13, 17, 18] The software offers 2D and 3D viewing, annotation, measurement tools, and both manual and automatic segmentation tools, including a rib extraction algorithm utilizing machine learning technology. [8, 12, 17] It supports DICOM images and is compatible with various imaging modalities. [8, 17, 18] uOmnispace.MI is designed to support clinical workflows in oncology, neurology, and cardiology, aiding clinicians in making timely and accurate diagnoses. [12, 13]

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • 2D and 3D medical image viewing
  • Annotation and measurement tools
  • Manual and automatic segmentation (including AI-based rib extraction)
  • Support for DICOM images across CT, MRI, PET, SPECT modalities
  • Remote multi-user access on a network
  • Image registration and lesion segmentation
  • Quantitative analysis and fusion imaging
  • Dynamic PET data analysis
  • Brain scan quantification (NeuroQ application)
  • Cardiac function analysis (Emory Cardiac Toolbox application)

Use Cases

  • Clinical workflows in oncology
  • Clinical workflows in neurology
  • Clinical workflows in cardiology
  • Interpretation and evaluation of medical examinations
  • Analysis of follow-up PET, CT, MR data for statistical analysis
  • Dedicated reporting for oncology, neurology, and cardiology

What Physicians Need to Know

Cardiac CT/MRI Analysis
uOmnispace offers comprehensive cardiac quantification packages for cardiac perfusion, function, and viability using CT and MR imaging. Specifically, uOmnispace.CT provides clinical packages like "CT Heart" for thorough diagnosis of coronary arteries, stenosis, plaque, and cardiac function analysis. It utilizes AI-driven algorithms for precise coronary artery extraction and heart chamber segmentation, achieving 91.6% accuracy in coronary artery extraction. uOmnispace.MR includes AI-driven segmentation for cardiac ventricular analysis and supports cardiac function analysis and flow analysis. The software also integrates with third-party applications like the Emory Cardiac Toolbox for perfusion and cardiac function analysis.
Coronary Artery Assessment
The 'CT Heart' package on the uOmnispace platform provides thorough diagnosis of coronary arteries, including stenosis and plaque analysis. It uses AI-driven algorithms for precise coronary artery extraction with 91.6% accuracy. Coronary Computed Tomography Angiography (CCTA) is utilized for non-invasive assessment of atherosclerotic plaques, their characteristics, and the degree of stenosis, aiding in the diagnosis of coronary artery disease and myocardial infarction risk assessment.
Heart Failure Risk Prediction
While not explicitly stated as 'heart failure risk prediction,' the comprehensive cardiac quantification for perfusion, function, and viability, along with detailed analysis of coronary artery disease and myocardial infarction risk, provides crucial data that can inform heart failure risk assessment.
Cardiac Monitoring Integration
uOmnispace is a scalable IT solution with standard interfaces for RIS/PACS/HIS, supporting multi-vendor interoperability and concurrent enterprise users. This indicates a capability for integration within existing hospital IT infrastructures, which would typically include cardiac monitoring systems.
Real-Time Alert Capability
The uOmnispace platform emphasizes intelligent insights and configurable workflows to manage high exam volumes. While not explicitly detailing 'real-time alerts,' its AI-powered workflow and pre-processing mechanisms for near-zero wait times suggest a focus on efficiency that could support timely identification of critical findings.
Physician Tip

Leverage uOmnispace's AI-driven cardiac CT and MRI analysis for efficient and accurate quantification of cardiac perfusion, function, and viability. Utilize the 'CT Heart' package for detailed coronary artery assessment, including stenosis and plaque analysis, benefiting from the high accuracy of AI-driven segmentation. The platform's interoperability allows for seamless integration into existing PACS/RIS, streamlining workflows and enabling comprehensive patient evaluation. Consider the insights from cardiac function and viability analyses to inform heart failure risk stratification.

uOmnispace is designed for scalable IT and enterprise integration, offering standard interfaces for RIS/PACS/HIS. It supports multi-vendor interoperability, allowing it to function within diverse healthcare IT environments. The platform can also run third-party applications like the Emory Cardiac Toolbox, expanding its analytical capabilities.

Details

Category Cardiology AI, Neurology AI, Oncology AI
Pricing Unknown
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Unknown
Integrations
EHR Not specified
Specialties Nuclear Medicine, Oncology, Radiology

What the Web Says

uOmnispace.MI is an advanced medical imaging software developed by United Imaging Healthcare, designed for physicians and trained medical technicians. It offers comprehensive 2D/3D viewing, annotation, measurement, and AI-enhanced segmentation and quantitative analysis tools for various modalities like PET, CT, MR, and SPECT scans. The software is particularly well-suited for deep diagnostic analysis in specialties such as oncology, neurology, and cardiology.

Overall: Mixed

Strengths

  • Advanced 2D/3D viewing and analysis tools
  • AI-enhanced segmentation and quantitative analysis
  • Supports multiple imaging modalities (PET, CT, MR, SPECT)
  • Specialized for oncology, neurology, and cardiology
  • Can be used as a standalone device or integrated with other systems
  • Windows-based UI, potentially more intuitive for some users

Limitations

  • Not intended for displaying digital mammography images for diagnosis in the U.S.
  • No specific user reviews found on G2 or Capterra for uOmnispace.MI directly.
  • General concerns about United Imaging (the parent company) regarding potential impact of trade wars and cybersecurity for US users.
  • Some Reddit users express general concerns about United Imaging's rapid growth and potential impact on technical/engineering support.

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

Last updated: 2026-07-19

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Press & Coverage

FDA
Medical Image Post-processing Software (uOmnispace.MI) 510(k) Premarket Notification
This regulatory announcement details the 510(k) clearance for uOmnispace.MI, a medical image post-processing software by Shanghai United Imaging Healthcare Co., Ltd., intended for viewing, processing, evaluating, and analyzing PET, CT, MR, and SPECT images. It outlines the device's indications for use, including oncology, neurology, and cardiology applications.
2023-12
FDA
K233176 - 510(k) Premarket Notification
This FDA document provides information on the 510(k) premarket notification for uOmnispace.MI by Shanghai United Imaging Healthcare Co., Ltd., listing the applicant and correspondent contacts, regulation number, and classification product code.
2026-05
Journal of Applied Clinical Medical Physics
Supported bridge position in oneu2010stop coronary and craniocervical CT angiography: A randomized clinical trial
This peer-reviewed article describes a clinical trial where uOmnispace.MI (R001, United Imaging Healthcare) was used as the workstation for analyzing images in a study on one-stop coronary and craniocervical CT angiography. The software was utilized for qualitative analysis and measurements of coronary arteries.
2024-11
BEUDAMED
EUDAMED basic UDI-DI information for uOmnispace.MI
This entry on BEUDAMED provides basic UDI-DI information for uOmnispace.MI, identifying Shanghai United Imaging Healthcare Co., Ltd. as the company responsible for the device.
2024-02
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing
This article discusses ground truthing for AI/ML SaMD and references uOmnispace.MI (K233176) from Shanghai United Imaging Healthcare Co., Ltd. in the context of regulatory predictability and adjudication patterns.
2025-09
CCPIT
Certificate of Free Sales (Australia) - uOmnispace.MI
Shanghai United Imaging Healthcare Co., Ltd. declared that a Certificate of Free Sales for various medical devices, including uOmnispace.MI, was approved by the Australian Department of Health and Aged Care.
2024-10
CCPIT
Certificate of Free Sale (Australia) - uOmnispace.MI, uWS-CT, uWS ME
Shanghai United Imaging Healthcare Co., Ltd. announced the approval of another Certificate of Free Sale by the Australian Government, which includes uOmnispace.MI, uWS-CT, and uWS ME.
2025-11
AccessGUDID
uOmnispace.MI Commercial Distribution Status
This AccessGUDID entry confirms that uOmnispace.MI, manufactured by Shanghai United Imaging Healthcare Co., Ltd., is currently in commercial distribution.
unknown

Videos

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

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Frequently Asked Questions

uOmnispace.MI is a post-processing software designed to integrate with existing imaging and hospital information systems via the DICOM 3.0 standard, allowing for remote multi-user access. It offers AI-based tools for 2D/3D viewing, annotation, measurement, and automatic segmentation, including rib extraction and lesion segmentation, across CT, MRI, PET, and SPECT modalities.
uOmnispace.MI has received FDA 510(k) clearance (K233176, building on K230039 for the uOmnispace platform). The platform is designed with security features such as end-to-end encryption, role-based access control (RBAC), and single sign-on (SSO) to help ensure compliance with healthcare data privacy regulations like HIPAA and GDPR.
Yes, uOmnispace.MI is specifically not intended to display digital mammography images for diagnosis in the U.S.. Physicians should always consult the official documentation for its complete indications for use and any other known limitations to ensure appropriate application in clinical practice.
uOmnispace.MI offers a comprehensive suite of 2D/3D viewing, annotation, and machine learning-based segmentation tools for multiple modalities (PET, CT, MR, SPECT), supporting diverse clinical workflows in oncology, neurology, and cardiology. Its validated AI algorithms, such as for rib extraction and lesion segmentation, provide a robust solution for advanced image post-processing and quantitative analysis.
The pricing model for uOmnispace.MI is typically subscription-based. For specific pricing details and information on different tiers or options tailored for individual practitioners or larger healthcare institutions, it is recommended to contact the vendor directly.
The AI performance of uOmnispace.MI's deep learning-based algorithms, such as for rib labeling and segmentation, has been validated through rigorous performance testing on large, diverse datasets. For example, rib segmentation on chest CT data demonstrated an average Dice coefficient of 0.855, exceeding acceptance criteria and indicating clinical equivalence to predicate devices.

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