uOmnispace.MI

by Shanghai United Imaging Healthcare Co.  · Based in China →Advanced Medical Imaging Software for Comprehensive Analysis
Nuclear Medicine Oncology Radiology

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Regulatory Status Disclosed

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.MI is a post-processing software for viewing, manipulating, evaluating, and analyzing PET, CT, MR, and SPECT images, supporting clinical workflows in cardiology. Specifically, the uOmnispace.MR Cardiac Function application is intended for functional analysis of cardiac MR images, and uOmnispace.MR Flow Analysis for flow MR images. The software supports tools for perfusion, vessel analysis, and cardiac function analysis from MR images. Performance testing included AI-driven cardiac ventricular segmentation, demonstrating high consistency with a Dice coefficient of 1.00. For CT, the uOmnispace.CT Heart application segments the heart, extracts coronary arteries, and provides analysis of vascular stenosis, plaque, and heart function. It also includes a Calcium Scoring application. The uOmnispace.CT Cardiovascular Combined Analysis integrates vessel and heart analysis for evaluating contrast-enhanced CT images, analyzing vascular and cardiac structures, and can be used for TAVR planning.
Coronary Artery Assessment
The uOmnispace.CT Heart application is designed to segment the heart and extract coronary arteries. It provides analysis of vascular stenosis and plaque, along with heart function. The uOmnispace.CT Cardiovascular Combined Analysis further integrates these features for comprehensive evaluation of vascular and cardiac structures from contrast-enhanced CT images.
Heart Failure Risk Prediction
United Imaging's uMR scanners integrate with MyoStrainu00ae software, a rapid MRI-based heart function test that quantifies the effects of disease, drugs, and ischemia across 48 heart segments in under 10 minutes. This tool is designed for early detection and management of cardiac disease, including cardiotoxic effects from cancer therapies, helping to identify heart dysfunction before irreversible damage or heart failure occurs. The uOmnispace.MR Cardiac Function application also contributes to assessing cardiac health through functional analysis of MR images.
Physician Tip

Leverage uOmnispace.MI's robust cardiac CT and MRI analysis capabilities for detailed structural and functional assessments, including AI-driven ventricular segmentation and coronary artery evaluation. Utilize the integrated MyoStrainu00ae software on United Imaging's uMR scanners for early detection of cardiac dysfunction and cardiotoxicity, which is crucial for proactive heart failure risk management, especially in oncology patients. The platform's ability to process and analyze multi-modality imaging (PET, CT, MR, SPECT) in a unified workflow can streamline diagnostic processes in complex cardiovascular cases.

uOmnispace.MI is a software-only medical device that supports DICOM images and is compatible with various imaging modalities like CT, MRI, and PET. It is designed to communicate effectively with various imaging and hospital information systems through the DICOM3.0 standard. The platform can run alone or integrate with other advanced commercially cleared applications, such as the uOmnispace.MI Emory Cardiac Toolbox for cardiac function analysis.

Details

Category Cardiology AI, Neurology AI, Oncology AI
Pricing Contact vendor
DeploymentSoftware-only medical device; can be stand-alone or integrated; compatible with off-the-shelf PCs; supports SaaS, on-premise, and hybrid models.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

uOmnispace.MI received FDA 510(k) Premarket Notification clearance (K233176) on December 20, 2023. [9, 12, 13] It is intended for viewing, manipulating, evaluating, and analyzing PET, CT, MR, and SPECT images, supporting interpretation and evaluation within healthcare institutions. [9, 13] It is not intended to display digital mammography images for diagnosis in the U.S. [8, 18]

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.

View all on YouTube

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 → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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