uMR Omega with uWS-MR-MRS

Radiology

Regulatory Status Disclosed

Overview

The uMR Omega with uWS-MR-MRS is a state-of-the-art 3.0T Magnetic Resonance (MR) diagnostic device, featuring an ultra-wide 75 cm bore designed to enhance patient comfort and accessibility, particularly for those with claustrophobia or obesity. It integrates advanced Artificial Intelligence (AI) technologies, including AI-assisted Compressed Sensing (ACS) and DeepRecon, to significantly accelerate scan times by up to 70% while maintaining or improving image quality. The system is equipped with uAIFI technology, SuperFlex Coils for improved patient comfort and signal reception, and EasyScan for streamlined workflow with automated scanning subtasks. It also offers a ‘Starlight Experience’ for patient calming and Qscan for quiet whole-body scanning. The accompanying uWS-MR-MRS software provides comprehensive tools for processing, reviewing, and analyzing MR studies. This tool is a medical imaging system for diagnostic purposes and radiotherapy planning, and its AI capabilities are focused on image acquisition and reconstruction, not on managing a physician directory.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • 75 cm Ultra-wide Bore
  • 3.0T Magnetic Field Strength
  • AI-assisted Compressed Sensing (ACS)
  • DeepRecon (Deep Learning Reconstruction)
  • uAIFI Technology Platform
  • Starlight Experience for Patient Comfort
  • Qscan (Quiet Scanning Technology)
  • SuperFlex Coils
  • EasyScan for Automated Workflow
  • Dual-source Millimeter-wave Radar for Free-breathing Scans

Use Cases

  • High-resolution diagnostic imaging of head, body, and extremities
  • Enhanced patient comfort for claustrophobic or obese patients
  • Accelerated MRI examinations
  • Intra-operative imaging
  • Radiotherapy treatment planning
  • Non-contrast renal and liver MRI

What Physicians Need to Know

DICOM Support & Standards
The uMR Omega MRI scanner and its associated uWS-MR software are designed to conform to NEMA and DICOM standards. The uWS-MR software supports the transfer of images in DICOM 3.0 format.
PACS Integration Method
The uWS-MR is a comprehensive software solution for viewing, manipulating, communicating, and storing medical images. It can transfer images over a medical imaging network and integrates with local clinical PACS systems.
Reading Room Workflow Impact
The uMR Omega features an ultra-wide 75 cm bore and a 680 lbs table capacity, enhancing patient comfort and access for bariatric and claustrophobic patients, potentially reducing cancelled scans. AI-assisted Compressed Sensing (ACS) can reduce scan times by up to 80% compared to Parallel Imaging, while DeepRecon, a deep learning-based reconstruction, improves image sharpness and signal-to-noise ratio (SNR), contributing to faster exams and enhanced diagnostic confidence. Features like a 5-minute stroke protocol and single breath-hold cardiac imaging further accelerate workflow. EasyScan automates scanning subtasks, and QScan reduces scan noise by up to 97%. The uWS-MR workstation offers advanced post-processing tools for various analyses, including MRS, perfusion, cardiac, vessel analysis, fMRI, and DTI.
AI Model Architecture (deep learning approach)
The system utilizes United Imaging's uAIFI Technology Platform, which integrates AI into both data acquisition and image reconstruction. Specifically, uAIFI ACS (AI-assisted Compressed Sensing) incorporates a deep learning neural network into the acquisition process for acceleration. uAI DeepReconu2122 is a deep learning (DL) based image reconstruction technology designed to simultaneously increase image sharpness and SNR.
Processing Speed (per study)
AI-assisted Compressed Sensing (ACS) can reduce scan times by up to 80% compared to conventional parallel imaging. The fully AI-powered imaging chain, including DeepRecon, aims to deliver ultra-high-quality images within 100 seconds. Specific protocols include an ultra-fast 5-minute stroke protocol and cardiac imaging with a single breath-hold.
FDA Clearance Pathway (510k/De Novo)
The uMR Omega MRI scanner received 510(k) clearance from the U.S. Food & Drug Administration (FDA). It is classified as a Class II Magnetic Resonance Diagnostic Device. The uWS-MR software has also received 510(k) clearances.
Supported Modalities (CT/MRI/X-ray/US)
The uMR Omega is a 3.0T Magnetic Resonance Imaging (MRI) scanner. The uWS-MR-MRS software is designed for processing, reviewing, and analyzing MR studies, including MR Spectroscopy (MRS).
Sensitivity & Specificity Data
Specific sensitivity and specificity data for the AI features of uMR Omega with uWS-MR-MRS for diagnostic interpretation are not explicitly provided in the search results. Information on deep learning models for reconstruction, such as a 95% success rate for automated CTO reconstruction, is mentioned in the context of other AI applications by United Imaging Intelligence.
Physician Tip

Leverage the uMR Omega's ultra-wide bore and quiet scanning (QScan) to enhance patient comfort, especially for bariatric, claustrophobic, pediatric, and geriatric patients, potentially reducing scan anxiety and improving compliance. Utilize the AI-assisted Compressed Sensing (ACS) and DeepRecon technologies to achieve significantly faster scan times and superior image quality, enabling quicker diagnoses and increased patient throughput. Explore the advanced post-processing capabilities of uWS-MR-MRS for detailed analysis, including MRS, fMRI, and DTI, to gain deeper insights for complex cases. Take advantage of specialized protocols like the 5-minute stroke protocol for acute imaging scenarios.

The uMR Omega and uWS-MR-MRS are built with DICOM 3.0 compliance, ensuring seamless integration with existing PACS and medical imaging networks for efficient image transfer, storage, and retrieval. The AI capabilities (ACS and DeepRecon) are embedded directly within the MRI system's imaging chain, from data acquisition to reconstruction, providing an integrated AI-powered workflow without requiring separate external AI engines for these core functions. The uWS-MR workstation serves as a dedicated hub for advanced post-processing and analysis of MR studies.

Details

Category Radiology & Imaging AI
Pricing Unknown
DeploymentOn-premise (Medical Facility)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The uMR Omega with uWS-MR-MRS received FDA 510(k) clearance (K220332) on October 27, 2022, as a Class II Magnetic Resonance Diagnostic Device (MRDD). It is indicated for producing sagittal, transverse, coronal, and oblique cross-sectional images, and spectroscopic images, to display internal anatomical structure and/or function of the head, body, and extremities.

Integrations
EHR Not specified
Specialties Radiology

What the Web Says

The United Imaging uMR Omega with uWS-MR-MRS is generally well-regarded for its advanced imaging capabilities and patient comfort features, particularly its wide bore and quiet operation. However, some users have noted concerns regarding the initial learning curve for the software and the availability of service and support in certain regions.

Overall: Positive

Strengths

  • Advanced imaging sequences and high-resolution images
  • Wide bore design improves patient comfort and reduces claustrophobia
  • Quiet operation enhances patient experience
  • Fast scanning times improve workflow efficiency
  • AI-powered features for image reconstruction and workflow optimization
  • Competitive pricing compared to other high-end MRI systems

Limitations

  • Steep learning curve for new users of the uWS-MR-MRS software
  • Service and support availability can be inconsistent in some regions
  • Integration with existing hospital IT systems can sometimes be challenging
  • Limited third-party accessory compatibility reported by some users
  • Initial investment cost can be significant for smaller facilities
  • Specific advanced features may require additional training

Based on reviews from: AuntMinnie.com, Radiology Today, MD Buyline, Healthcare IT News, Reddit (r/radiology, r/medicalphysics), LinkedIn discussions (healthcare professionals)

Last updated: 2026-07-19

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Press & Coverage

Physician Ai Tools / Imaging Technology News
uMR Omega with uWS-MR-MRS: medical AI radiology & imaging ai for physicians
This article from April 2026 discusses the uMR Omega with uWS-MR-MRS as a medical AI radiology and imaging AI tool for physicians, highlighting its features, pricing, HIPAA & FDA compliance, and EHR integration.
2026-04
Orthogonal
SaMD Cleared by the FDA: The Ultimate Running List
This comprehensive list of FDA-cleared Software as a Medical Devices (SaMD) includes 'UMR Omega With uWS-MR-MRS' by Shanghai United Imaging Healthcare Co., Ltd., with a clearance date of October 27, 2022, for radiology.
2024-10
accessdata.fda.gov
FDA 510(k) Premarket Notification K220332
An FDA document from April 2024 details the 510(k) clearance for the uMR Omega with uWS-MR-MRS, classifying it as a Class II magnetic resonance diagnostic device (MRDD) manufactured by Shanghai United Imaging Healthcare Co., Ltd.
2024-04
FDA
K220332 - 510(k) Premarket Notification
This FDA 510(k) Premarket Notification, updated in May 2026, confirms the clearance of the uMR Omega with uWS-MR-MRS by Shanghai United Imaging Healthcare Co., Ltd. as a Magnetic Resonance Imaging System.
2026-05
accessdata.fda.gov
FDA 510(k) Substantial Equivalence Determination K220332
An FDA letter from October 2022 confirms the substantial equivalence determination for the uMR Omega with uWS-MR-MRS, outlining its intended use as a magnetic resonance diagnostic device and detailing modifications to the system.
2022-10
unknown
Shanghai United Imaging Healthcare Co., Ltd radiology AI products
This entry indicates that uMR Omega with uWS-MR-MRS is a radiology AI product from Shanghai United Imaging Healthcare Co., Ltd., cleared on October 27, 2022, for image analysis/processing using MRI.
2022-10
510k Monitor
K260113: uMR Astra u2014 FDA 510(k) clearance
A May 2026 article on 510k Monitor mentions uMR Omega with uWS-MR-MRS (K220332) as a predicate device in the lineage for the uMR Astra system's FDA 510(k) clearance, highlighting its role in the evolution of United Imaging's MR diagnostic devices.
2026-05
unknown
Shanghai United Imaging Healthcare Co L T D FDA Filings
This filing record indicates that Shanghai United Imaging Healthcare Co., Ltd. received FDA clearance for 'UMR Omega With UWS-MR-MRS' on October 27, 2022.
2022-10

Videos

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Frequently Asked Questions

The uMR Omega integrates AI-assisted Compressed Sensing (ACS) during data acquisition and DeepRecon for image reconstruction, enabling a fully AI-powered imaging chain. This technology delivers ultra-high-quality images within significantly reduced scan times, potentially improving patient throughput and diagnostic confidence by providing clearer, sharper images.
The uMR Omega with uWS-MR-MRS is cleared by the FDA as a Class II Magnetic Resonance Diagnostic Device, conforming to NEMA and DICOM standards. This regulatory clearance covers the device's intended use, including its AI-assisted features like ACS and DeepRecon, ensuring it meets established safety and performance criteria for medical devices.
While AI significantly enhances speed and image quality, physicians should be aware that, like all AI in healthcare, it is a tool to assist diagnosis and not replace clinical judgment. Specific limitations could relate to the generalizability of AI models to rare pathologies or unusual patient anatomies, and the need for ongoing validation and understanding of the AI's performance characteristics in diverse clinical scenarios. The system is designed to address challenges like motion artifacts and image noise, but these remain considerations in MRI.
Specific pricing for the uMR Omega with uWS-MR-MRS system is not publicly disclosed and typically varies based on configuration, regional factors, and service agreements. United Imaging offers 'All-In Configurations' and 'Software Upgrades for Life,' which may impact the overall cost of ownership by including all software and future upgrades.
Yes, other manufacturers offer wide-bore MRI systems, and many are integrating AI for image acceleration and quality enhancement. While the uMR Omega boasts a 75cm ultra-wide bore and specific AI technologies like ACS and DeepRecon, physicians may find comparable features in high-field MRI systems from other leading vendors, such as Philips, Siemens, GE, and Toshiba, which also focus on patient comfort and advanced imaging.
The uMR Omega features a 75cm ultra-wide bore, the widest available in a 3T MRI, significantly improving patient comfort and accessibility for bariatric or claustrophobic individuals. Its AI technologies, such as AI-assisted Compressed Sensing (ACS) and DeepRecon, drastically reduce scan times by up to 70-80%, further enhancing patient experience and reducing motion artifacts.

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