uCT ATLAS Astound with uWS-CT-Dual Energy Analysis

Oncology Pulmonology Radiology

Not disclosed
Regulatory Status Disclosed

Overview

The uCT ATLAS Astound with uWS-CT-Dual Energy Analysis is an advanced multi-slice computed tomography (CT) X-ray system developed by Shanghai United Imaging Healthcare Co. It integrates cutting-edge image acquisition hardware, reconstruction, and dual-energy analysis software. This system is designed to produce cross-sectional images of the whole body through computer reconstruction of X-ray transmission data. It features an ultra-wide 82 cm bore and a 700 lbs (318 kg) maximum table load capacity, accommodating a wide range of patients. The uCT ATLAS Astound incorporates AI-empowered workflows, including the uAI Vision 3D camera for intelligent patient positioning, scanning, and processing, aiming to provide an efficient, standardized, and personalized scanning experience while reducing radiation dose. The uWS-CT-Dual Energy Analysis is a post-processing software package that utilizes images acquired with different tube voltages and/or currents to visualize information based on varying attenuation coefficients of anatomical regions, providing insights into chemical composition.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Multi-slice Computed Tomography (CT) scanner
  • uWS-CT-Dual Energy Analysis software for material differentiation
  • AI-empowered workflow with uAI Vision 3D camera for intelligent positioning
  • Deep IR (AIIR) reconstruction for noise reduction and improved detectability
  • 0.25-second rotation speed for high temporal resolution and fast scanning
  • 82 cm ultra-wide bore and 700 lbs (318 kg) table load capacity
  • Low dose CT lung cancer screening capability
  • Applicable for head, whole body, cardiac, and vascular imaging
  • Dynamic whole organ imaging and fast body/vascular imaging
  • Software upgrades for life (for uCT ATLAS model, likely applies to Astound)

Use Cases

  • Whole-body cross-sectional imaging
  • Cardiac imaging, including one-beat cardiac scans and fast helical CTA
  • Low-dose CT lung cancer screening for early detection of lung nodules
  • Vascular imaging
  • Emergency department and trauma imaging
  • Total stroke imaging (NCCT, CTA, 4D Dynamic CTA, CTP analysis)

What Physicians Need to Know

DICOM Support & Standards
The system supports standard image acquisition, reconstruction, and post-reconstruction analysis, implying compatibility with DICOM for image handling and interoperability within a radiology environment.
PACS Integration Method
While not explicitly detailed, the AI-empowered workflow and advanced post-processing capabilities of the uCT ATLAS Astound necessitate seamless integration with PACS for efficient image archiving, retrieval, and incorporation into the clinical workflow.
Reading Room Workflow Impact
Features an AI-empowered workflow with intelligent positioning, scanning, and processing, designed to offer operational efficiencies and simplify complex exams. The uAI Vision 3D camera provides an efficient, standardized, and personalized scanning experience. Fast scanning capabilities, including a 0.25-second gantry rotation and one-beat cardiac solutions, enhance throughput. Advanced algorithms like Auto ALARA, CardioXPhase, and CardioCapture improve image quality and diagnostic accuracy in challenging CCTA cases.
AI Model Architecture (deep learning approach)
The system is 'Born with AI' and utilizes AI-empowered technologies. Key components include 'Deep IR (uAI AI-IR)', a deep learning reconstruction method that combines model-based iterative reconstruction to reduce noise, artifacts, and improve low contrast detectability and spatial resolution. The uAI Vision 3D camera uses deep learning for 3D segmentation and accurate patient positioning. Specific deep learning modules like Spatial Anatomical Dependency (SAD) and Hierarchical Topology Learning (HTL) are part of the uAI Discover Coronary CT solution, and CardioCapture employs deep learning for coronary artery motion correction.
Processing Speed (per study)
Features an ultra-fast 0.25-second gantry rotation speed, enabling rapid image acquisition. This speed facilitates one-beat cardiac scans and dynamic whole-organ imaging, significantly reducing motion artifacts and improving patient throughput.
FDA Clearance Pathway (510k/De Novo)
The uCT ATLAS and uCT ATLAS Astound with uWS-CT-Dual Energy Analysis received FDA clearance through the 510(k) pathway. Specific 510(k) numbers include K203448, K223028, and K243617.
Supported Modalities (CT/MRI/X-ray/US)
This tool is specifically designed for Computed Tomography (CT) imaging. It is a 640-slice CT system applicable to head, whole body, cardiac, and vascular CT, and is intended for low-dose CT lung cancer screening. The uWS-CT-Dual Energy Analysis is a software package that utilizes UIH CT images.
RSNA/ACR Validation
The uCT ATLAS was launched at RSNA, and United Imaging regularly showcases its AI technologies and the uCT ATLAS at RSNA. Clinical evaluations and experiences with the uCT ATLAS, particularly for CCTA, have been presented at scientific meetings like SCCT and featured in United Imaging's uINNOVATION-GLOBAL magazine.
Physician Tip

Leverage the AI-empowered workflow, including intelligent positioning and advanced reconstruction (Deep IR/uAI AI-IR), to optimize image quality at reduced doses, especially for challenging cases like cardiac imaging with high heart rates or patients with high BMI. Utilize the uWS-CT-Dual Energy Analysis for enhanced tissue characterization. The rapid scanning speed and one-beat cardiac capabilities are particularly beneficial for pediatric, trauma, and cardiac patients, minimizing motion artifacts. The 'Software Upgrades for Life' ensures continuous access to the latest advancements, allowing for expanded clinical services without additional software investment.

The system is designed to integrate into existing radiology workflows, implicitly supporting DICOM for image transfer and requiring seamless connectivity with PACS for efficient image archiving, retrieval, and post-processing. Its AI-driven features are integrated directly into the scanner's workflow, streamlining the acquisition and reconstruction process.

Details

Category Radiology & Imaging AI
Pricing Not disclosed — Contact vendor for pricing information
DeploymentOn-premise (hardware with integrated software)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The uCT ATLAS Astound with uWS-CT-Dual Energy Analysis (K243617) received a Substantially Equivalent (SE) decision from the FDA on May 16, 2025. It is classified as a Class II Computed Tomography X-ray System (21 CFR 892.1750) and is intended for whole-body imaging, including head, cardiac, and vascular X-ray CT, as well as low-dose CT lung cancer screening.

Integrations
EHR Not specified
Specialties Oncology, Pulmonology, Radiology

What the Web Says

The United Imaging uCT ATLAS Astound with uWS-CT-Dual Energy Analysis is a computed tomography (CT) x-ray system designed for whole-body imaging, including head, cardiac, and vascular applications. It aims to provide exceptional image quality at a low radiation dose and features AI-powered workflows for efficiency. The dual-energy analysis software enhances diagnostic accuracy by differentiating materials based on their attenuation coefficients at different energy levels.

Overall: Positive

Strengths

  • Exceptional image quality at a low radiation dose.
  • Fast scanning capabilities, particularly beneficial for cardiac, dynamic whole organ, and vascular imaging.
  • AI-empowered workflow for efficient, standardized, and personalized scanning.
  • Ultra-wide 82 cm bore and 700 lbs table weight capacity accommodate a wide range of patients, including larger individuals and those in trauma.
  • Dual-energy analysis provides better diagnostic performance by differentiating materials and potentially reducing contrast agent use.
  • All advanced applications and post-reconstruction analysis software, along with software upgrades for life, are included.

Limitations

  • One review noted that the predicate device could use a dual energy function on both axial and helical scan modes, but the proposed device only on helical scan mode, though this difference was not deemed to raise new safety and effectiveness concerns.
  • Some dual-energy CT systems, depending on their technology, may have limitations such as a restricted field of view for dual-energy imaging in larger patients or require specific scan protocols that increase scan time.
  • The increase in images and data from dual-energy CT can present workflow challenges.
  • Limited public reviews from physicians, healthcare IT, tech reviewers, Reddit, G2, and Capterra were found, making a comprehensive sentiment analysis challenging.

Based on reviews from: Innolitics (FDA 510(k) K243617), FDA.report (uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT), YouTube (United Imaging uCT ATLAS Testimonials (Carrollton Regional Medical Center)), accessdata.fda.gov (February 16, 2023 Shanghai United Imaging Healthcare Co., Ltd. Xin Gao Regulatory Affairs Manager), United-Imaging (uCTu00ae ATLAS product page), Scribd (FDA Approval for uCT ATLAS Astound), FDA (K243617 - 510(k) Premarket Notification), YouTube (Sponsored Symposium | CCTA with the uCTu00ae ATLAS - Initial Experience), PMC (Pros and Cons of Dual-Energy CT Systems: u201cOne Does Not Fit Allu201d), AuntMinnie (United Imaging unveils new CT scanner at RSNA 2020), Reddit (UIH uCT 960+ evaluation?), ICE Magazine (United Imaging uCT ATLAS Earns FDA Clearance), Reddit (Dual energy CT), BioSpace (United Imaging Announces FDA Clearance for its Versatile Ultra-Premium Scanner, the uCTu00ae ATLAS), ICE Magazine (United Imaging uCT systems), Radiology Today (A Different Energy u2014 CT Manufacturers Develop Different Approaches to Spectral Scanning), Duke Health (Powerful Imaging Technologies Offer Early Stage Diagnoses), G2 (Best AI Medical Diagnostic Platforms: User Reviews from July 2026), Capterra (Best Radiology Software 2026), PubMed (Utility of Dual-Energy Computed Tomography in Clinical Conundra)

Last updated: 2026-07-19

Ratings & Reviews

Rate uCT ATLAS Astound with uWS-CT-Dual Energy Analysis

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Press & Coverage

FDA.report
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT - FDA.report
This document details the FDA clearance for the uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, a computed tomography x-ray system intended for whole-body imaging and low-dose lung cancer screening. It outlines the device's capabilities, including its dual-energy analysis software for visualizing information from low and high energy spectra.
2023-11
FDA
K243617 - 510(k) Premarket Notification - FDA
This FDA premarket notification (510(k)) confirms the clearance of uCT ATLAS Astound with uWS-CT-Dual Energy Analysis by Shanghai United Imaging Healthcare Co., Ltd. The document provides regulatory information and contact details for the applicant.
2025-05
Scribd (reposting FDA document)
FDA Approval for uCT ATLAS Astound | PDF | Ct Scan | Medical Device - Scribd
This document is an FDA letter confirming the clearance of the uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, stating it is substantially equivalent to predicate devices. It details the device's intended use for cross-sectional imaging and dual-energy analysis.
2023-02
Innolitics
uCT ATLAS with uWS-CT-Dual Energy Analysis (K243617) u2014 FDA 510(k) | Innolitics
Innolitics provides an overview of the FDA 510(k) clearance for uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, highlighting its device facts, indications for use, and technological characteristics. The system is intended for whole-body CT imaging and low-dose lung cancer screening.
unknown
Constat
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis - Constat
Constat presents details on the FDA 510(k) clearance (K243617) for uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, cleared on May 16, 2025. It notes the device's use of deep learning technology for image reconstruction and motion correction in cardiac scanning.
2025-01
accessdata.fda.gov
February 16, 2023 Shanghai United Imaging Healthcare Co., Ltd. Xin Gao Regulatory Affairs Manager No. 2258 Chengbei Rd., Jia - accessdata.fda.gov
This FDA letter confirms the substantial equivalence determination for the uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, outlining its regulatory classification and product code. It also mentions the device's intended use for low-dose CT lung cancer screening.
2023-02
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances - Innolitics
This article from Innolitics includes the uCT ATLAS Astound with uWS-CT-Dual Energy Analysis among the 2025 AI/ML-related FDA 510(k) clearances in cardiology. It highlights the growing trend of AI/ML in medical device clearances.
2026-01

Videos

Product demos, reviews, and walkthroughs for uCT ATLAS Astound with uWS-CT-Dual Energy Analysis.

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Frequently Asked Questions

The uCT ATLAS Astound integrates AI through its uAI Vision 3D camera, which enables an AI-empowered workflow for intelligent patient positioning, scanning, and processing, simplifying complex exams. Additionally, its uWS-CT-Dual Energy Analysis software leverages spectral information from low and high energy acquisitions to provide enhanced material differentiation and quantitative data, aiding in improved diagnosis.
The uCT ATLAS Astound with uWS-CT-Dual Energy Analysis has received FDA 510(k) clearance, indicating it is substantially equivalent to legally marketed predicate devices. This clearance covers the computed tomography x-ray system and its post-processing dual-energy analysis software.
While dual-energy CT offers significant advantages, general limitations can include increased system complexity and, in some cases, potentially higher radiation doses compared to single-spectrum CT, although AI-powered reconstruction aims to mitigate this. The intricate workflow and intrinsic technical constraints of dual-energy imaging also require careful consideration for appropriate clinical use.
Alternatives include other advanced CT systems from major vendors like Philips, Siemens, Toshiba, and GE, many of which also offer dual-energy capabilities and increasingly integrate AI for image reconstruction and workflow optimization. For example, Philips' Spectral CT Verida system also features AI-powered deep learning reconstruction and always-on spectral imaging.
Specific pricing for the uCT ATLAS Astound with uWS-CT-Dual Energy Analysis is not publicly detailed in the search results, but a marketplace listing indicates a range for the uCT ATLAS. Factors influencing the cost typically include the specific configuration, additional software packages, service agreements, installation requirements, and regional market conditions.
As a medical device with FDA clearance, the uCT ATLAS Astound and its associated software are expected to comply with stringent cybersecurity and data privacy regulations, such as those outlined in the Code of Federal Regulations, Title 21, Part 820 (Quality System Regulation) and guidance for cybersecurity in medical devices. This ensures that patient data processed by the AI components is handled securely and confidentially.
While specific training details are not provided, effective utilization of advanced CT systems like the uCT ATLAS Astound, particularly its AI-powered workflow and dual-energy analysis, typically requires comprehensive training for technologists and radiologists. This training would cover intelligent positioning, scanning protocols, post-processing techniques, and interpretation of dual-energy derived images to maximize diagnostic utility.

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