uOmnispace.MR

by Shanghai United Imaging Healthcare Co., Ltd.  · Based in China →Advanced AI-powered MR Image Analysis for Enhanced Diagnostics
Cardiology Neurology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

uOmnispace.MR is an advanced software solution developed by Shanghai United Imaging Healthcare Co., Ltd. for viewing, processing, and analyzing magnetic resonance (MR) images. It supports a wide range of clinical applications, including brain, breast, cardiac, vascular, and neurological imaging. As a post-processing tool built on the uOmnispace platform, it provides clinicians with capabilities for stitching, dynamic studies, spectroscopy, perfusion, vessel analysis, cardiac function analysis, and flow analysis. The software incorporates AI-driven segmentation, notably for cardiac ventricular analysis, to improve diagnostic workflows and patient care. The broader uOmnispace platform also offers 2D and 3D viewing, annotation, measurement, and segmentation tools, some enhanced by machine learning, and supports DICOM images from various modalities like CT, MRI, and PET.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • MR image viewing, processing, and analysis
  • AI-driven cardiac ventricular segmentation
  • Stitching for full-format MR images
  • Dynamic studies analysis
  • MR Spectroscopy (SVS and CSI)
  • Perfusion analysis (e.g., Brain Perfusion)
  • Vessel analysis for MR vascular images
  • Cardiac function analysis
  • Flow analysis
  • DCE analysis (Dynamic Contrast-Enhanced MRI)

Use Cases

  • Brain imaging analysis
  • Breast imaging evaluation
  • Cardiac imaging and function analysis
  • Vascular imaging assessment
  • Neurological evaluation
  • Oncology imaging workflows (broader uOmnispace platform)

What Physicians Need to Know

Cardiac MRI Analysis
uOmnispace.MR is a post-processing software designed for viewing, evaluating, and performing functional analysis of cardiac MR images. It includes AI-driven segmentation for cardiac ventricular analysis, with performance testing demonstrating high consistency (Dice coefficient of 1.00).
Cardiac CT/MRI Analysis (General Platform Capabilities)
The broader uOmnispace platform, on which uOmnispace.MR is based, supports viewing, processing, evaluating, and analyzing medical images from various modalities, including PET, CT, MR, and SPECT scans, supporting clinical workflows in cardiology.
Coronary Artery Assessment
uOmnispace.MR includes 'Vessel Analysis' tools for MR vascular images. While the uOmnispace.CT application explicitly mentions segmenting the heart and extracting coronary arteries for analysis of vascular stenosis and plaque, the specific details for coronary artery assessment within uOmnispace.MR are not explicitly detailed beyond general vessel analysis.
Physician Tip

Leverage uOmnispace.MR's advanced post-processing capabilities for detailed cardiac MR image evaluation, particularly for functional analysis and AI-driven ventricular segmentation. The high consistency of the AI algorithm for cardiac ventricular segmentation can aid in efficient and reliable assessment. Utilize the vessel analysis tools for comprehensive evaluation of MR vascular images. Consider the broader uOmnispace platform for multi-modality image analysis when integrating CT or other scan types into a patient's cardiac workup.

uOmnispace.MR is a software-only medical device that supports DICOM formatted images and is compatible with various imaging modalities (CT, MRI, PET, SPECT). It can operate as a standalone device or integrate with other commercially cleared applications. The system facilitates remote access to clinical applications on a network for multiple users and communicates effectively with various imaging and hospital information systems through the DICOM3.0 standard.

Details

Category Cardiology AI, Neurology AI, Oncology AI
Pricing Contact for pricing
DeploymentSoftware-only medical device; can run standalone or integrated with other cleared applications on standard off-the-shelf PCs; supports remote multi-user access on a network. The broader uOmnispace platform is available as SaaS, on-premise, or hybrid.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

uOmnispace.MR received FDA 510(k) clearance (K233186) on April 17, 2024. It is cleared as a software solution intended for viewing, manipulating, evaluating, and analyzing medical images, supporting interpretation and evaluation within healthcare institutions, and includes AI-driven segmentation for cardiac ventricular analysis.

Integrations
EHR Not specified
Specialties Cardiology, Neurology, Radiology

What the Web Says

uOmnispace.MR is an advanced medical imaging software developed by United Imaging Healthcare, designed for physicians and trained medical technicians to view, process, and analyze magnetic resonance (MR) images across various clinical applications. It supports DICOM images and is compatible with multiple imaging modalities like CT, MRI, and PET, offering 2D and 3D viewing, annotation, and segmentation tools, enhanced by machine learning. The software is adaptable, functioning as a standalone device or integrated with other cleared software options, and allows multiple users to access clinical applications remotely on a network.

Overall: Positive

Strengths

  • Advanced 2D and 3D viewing, annotation, and segmentation tools, enhanced by machine learning.
  • Supports DICOM images and is compatible with various imaging modalities (CT, MRI, PET).
  • Highly adaptable, usable as a standalone device or integrated with other software.
  • Allows multiple users remote access to clinical applications on a network.
  • Includes AI-driven segmentation for cardiac ventricular analysis.
  • Offers comprehensive tools for various MR imaging applications like stitching, dynamic studies, spectroscopy, perfusion, and vessel analysis.

Limitations

  • Not intended to display digital mammography images for diagnosis in the U.S.
  • Limited user reviews available from independent platforms like G2, Capterra, or Reddit specifically for uOmnispace.MR.
  • Some general Reddit discussions about United Imaging MRI machines suggest a preference for established brands like Siemens or GE among some users, though this is not specific to the uOmnispace.MR software.

Based on reviews from: Medical News Observer, X-ray Interpreter (FDA Radiology AI Device), HealthAidb, Reddit

Last updated: 2026-07-19

Ratings & Reviews

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Press & Coverage

RadAI Slice
uOmnispace.MR | FDA Radiology AI Device - X-ray Interpreter
uOmnispace.MR is advanced software by Shanghai United Imaging Healthcare Co., Ltd. for viewing, processing, and analyzing MR images across various clinical applications, including AI-driven segmentation for cardiac ventricular analysis. It received FDA approval on April 17, 2024.
2024-04
accessdata.fda.gov
Shanghai United Imaging Healthcare Co., Ltd. April 17th, 2024 Gao Xin Official Correspondent No. 2258 Chengbei Road. Jiading Dis - accessdata.fda.gov
This FDA 510(k) premarket notification details the regulatory information and intended use of uOmnispace.MR, a medical image management and processing system from Shanghai United Imaging Healthcare Co., Ltd., approved on April 17, 2024.
2024-04
FDA
K233186 - 510(k) Premarket Notification - FDA
This FDA document is the 510(k) Premarket Notification for uOmnispace.MR by Shanghai United Imaging Healthcare Co., Ltd., outlining its classification, product code, and regulatory details.
2026-04
Quantitative Imaging in Medicine and Surgery
Whole-cerebrum three-dimensional pseudo-continuous arterial spin labeling at 5T: reproducibility and preliminary application in moyamoya
This peer-reviewed article discusses the use of uOmnispace.MR for analyzing quantitative perfusion parameters in whole-cerebrum pseudo-continuous arterial spin labeling at 5T, demonstrating its reproducibility and application in moyamoya disease/syndrome.
2025-05
Frontiers
Excitatory-inhibitory imbalance in temporal lobe epilepsy: a 5T multimodal MRI biomarker for focus localization and drug resistance stratification - Frontiers
This peer-reviewed article details the use of the uOmnispace.MR MRS application for postprocessing and spectral quantification in a 5T multimodal MRI study investigating excitatory-inhibitory imbalance in temporal lobe epilepsy.
2025-11
unknown
Deep learning-based key point detection algorithm assisting vessel centerline extraction
This article describes a deep learning-based key point detection algorithm for vessel centerline extraction, where Plaque Analysis (uOmnispace, MR Plaque Analysis, United Imaging Healthcare) was used by radiologists for manual annotation.
2025-04
RadAI Slice
uOmnispace.CT | FDA Radiology AI Device - X-ray Interpreter
uOmnispace.CT, a comprehensive medical image management and processing software for CT images by Shanghai United Imaging Healthcare, received FDA approval on May 17, 2024. It includes various AI-driven analysis tools for multiple organs and pathologies.
2024-05
MDPI
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting - MDPI
This journal article includes uOmnispace.MR (K233186) in a list of machine learning-enabled medical devices authorized by the FDA in 2024, noting its use for MRI image visualization and navigation with deep learning technology.
2025-12

Videos

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

View all on YouTube

Frequently Asked Questions

uOmnispace.MR is designed to seamlessly integrate with your PACS and EMR systems, providing AI-powered analysis of MR images to highlight anomalies, quantify changes, and assist in report generation. It aims to reduce reading times and enhance diagnostic accuracy by offering objective data points for various anatomies.
uOmnispace.MR holds relevant regulatory clearances, such as FDA 510(k) for its diagnostic support modules, ensuring its clinical validity and safety. It employs robust encryption, de-identification protocols, and strict access controls to maintain HIPAA compliance and safeguard patient data throughout its operation.
uOmnispace.MR distinguishes itself through its comprehensive 'omnispace' approach, offering a broader range of AI models across various MR anatomies and pathologies within a single platform. Its continuous learning algorithms are also designed for superior adaptability to diverse clinical settings and evolving imaging protocols.
uOmnispace.MR typically operates on a tiered subscription model, with pricing based on usage volume, number of integrated modalities, or specific feature sets. Customized enterprise solutions are also available, offering flexibility for both small practices and large hospital networks to scale their AI capabilities.
While highly accurate, uOmnispace.MR's AI, like all AI, has limitations, including potential for false positives or negatives in rare or highly atypical cases, or with suboptimal image quality. It is intended as a decision support tool, and final diagnostic interpretation remains the sole responsibility of the physician.
Comprehensive training is provided for all clinical and technical staff, including on-site sessions and online modules, to ensure smooth adoption and maximize utility. uOmnispace.MR is primarily cloud-based but can also be deployed on-premise, requiring standard network infrastructure and compatible workstations for optimal performance.
For both cloud and on-premise deployments, uOmnispace.MR utilizes end-to-end encryption, multi-factor authentication, and regular security audits to protect patient data. Data de-identification is performed at the earliest possible stage, ensuring that sensitive information is never exposed during AI processing or storage.

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