Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System

by Canon Medical Systems Corporation  · Based in Japan → — Designed for deep intelligence.
Cardiology Interventional Radiology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

The Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System from Canon Medical Systems Corporation is a cutting-edge whole-body multi-slice helical CT scanner that integrates advanced artificial intelligence (AI) technologies with spectral imaging capabilities. This system is engineered to provide physicians with deep clinical insights, enabling more confident and informed diagnoses across various patient care cycles.

Key to its innovation are Deep Learning Reconstruction (DLR) algorithms, including Advanced intelligent Clear-IQ Engine (AiCE) and Precise IQ Engine (PIQE), which distinguish true signal from noise to deliver sharp, clear, and distinct images at high speeds while minimizing radiation dose. The spectral imaging system harnesses rapid kV switching with patient-specific mA modulation, allowing for comprehensive spectral data analysis, including quantification and multi-layered images for detailed material differentiation.

The system also features automated workflows, such as the 3D Landmark Scan and AI-enabled Anatomical Landmark Detection, to optimize productivity and ensure consistent scan planning. Its wide-area detector (16 cm) facilitates fast acquisitions and whole-organ imaging in a single rotation, including advanced cardiac studies with built-in motion correction (CLEAR Motion Cardiac).

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Deep Learning Reconstruction (AiCE and PIQE)
  • Deep Learning Spectral Imaging with rapid kV switching
  • Automated workflow with AI-enabled Anatomical Landmark Detection
  • 16 cm wide-area detector for whole-organ imaging
  • CLEAR Motion Cardiac for motion correction in cardiac imaging
  • Ultra-low dose scanning with SilverBeam Filter
  • Intuitive User Experience (INSTINX) for enhanced productivity
  • Material differentiation and quantification
  • Low-noise, high-resolution image quality
  • CT Fluoroscopy Interface for interventional procedures

Use Cases

  • Cardiac CT angiography and assessment
  • Lung cancer screening
  • Renal stone analysis and material differentiation
  • Brain analysis and iodine mapping
  • Angiography and vascular studies
  • General diagnostic CT imaging

What Physicians Need to Know

DICOM Support & Standards
The Aquilion ONE / PRISM Edition, like other Canon Medical Systems products, provides DICOM Conformance Statements, detailing support for various DICOM Service Classes, Information Objects, and Communication protocols to ensure compatibility within a DICOM compliant hospital network.
PACS Integration Method
The system offers a fully integrated, end-to-end spectral workflow, with images delivered directly to the reading station. Spectral applications, including those from Vitrea Advanced Visualization, are scalable from a single workstation to a hospital-wide network, supporting seamless PACS integration.
Reading Room Workflow Impact
Designed for deep intelligence, the system integrates AI technology to maximize conventional and spectral CT capabilities and automated workflows, providing intelligent clinical insights. It aims to reduce workflow steps, ensure consistent results, and simplify operation. Deep Learning Spectral CT automatically reconstructs monochromatic images, material-specific reconstructions, and iodine maps for direct delivery to the reading station.
AI Model Architecture (deep learning approach)
The system incorporates several Deep Learning Reconstruction (DLR) technologies: n- **Advanced intelligent Clear-IQ Engine (AiCE)**: Uses deep learning (Deep Convolutional Neural Network methods) to distinguish true signal from noise, delivering sharp, clear images at fast speeds across the whole body.n- **Deep Learning Spectral Reconstruction**: Combines rapid kV switching with patient-specific mA modulation and DLR to provide excellent energy separation and low-noise properties for spectral imaging, transforming multi-energy raw data into separated sinograms.n- **Precise IQ Engine (PIQE)**: A super-resolution DLR technology that enhances spatial resolution and reduces noise (e.g., 45% reduced noise for in-stent visualization) for cardiac applications, utilizing Deep Convolutional Neural Networks.
Processing Speed (per study)
The Aquilion ONE / PRISM Edition features a 0.275 second whole-heart acquisition with rapid kVp switching. It can achieve up to 80 frames per second reconstruction speed. The Aquilion ONE / INSIGHT Edition, a related system, also mentions an ultra-fast 0.24 second rotation speed.
FDA Clearance Pathway (510k/De Novo)
The Aquilion ONE / PRISM Edition received 510(k) clearance (K192828) for its Deep Learning Spectral capabilities in February 2020. Subsequent versions (V10.4 and V10.12) also received 510(k) clearances (K203225 and K220038 respectively). Expanded capabilities for cardiovascular applications received 510(k) clearance in April 2021.
Supported Modalities (CT/MRI/X-ray/US)
This system, the Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System, is a whole-body multi-slice helical Computed Tomography (CT) scanner.
RSNA/ACR Validation
Canon Medical Systems has presented its CT technologies, including the Aquilion ONE / GENESIS Edition and Aquilion Precision, at RSNA. While these indicate industry presence and scientific discourse, specific validation or endorsement by RSNA/ACR for the AI features of the Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System are not explicitly detailed in the provided information.
Physician Tip

Leverage the integrated Deep Learning Reconstruction (DLR) technologies (AiCE, PIQE, Deep Learning Spectral) to achieve superior image quality with reduced noise and enhanced spatial resolution, particularly beneficial for complex cardiac cases, heavily calcified vessels, and spectral material characterization. Utilize the automated workflows and spectral applications for streamlined analysis and confident diagnoses, especially for renal stone differentiation and iodine mapping. The rapid acquisition speeds (e.g., one-beat cardiac imaging) can significantly improve patient throughput and reduce motion artifacts.

The Aquilion ONE / PRISM Edition is designed for seamless integration into existing hospital networks, supporting DICOM standards for image transfer and communication. Its spectral applications, including those from Vitrea Advanced Visualization, are scalable for PACS integration, allowing for comprehensive data analysis directly at the reading station or across a hospital-wide network. Cybersecurity documentation is included as part of its FDA submissions, indicating attention to secure integration.

Details

Category Radiology & Imaging AI
Pricing Contact for pricing — Pricing available upon request from Canon Medical Systems Corporation.
DeploymentOn-premise (hardware)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

Cleared by the FDA under K192828 on February 13, 2020. It is a Class II computed tomography x-ray system (Product Code JAK), indicated to acquire and display cross-sectional volumes of the whole body, including the head, with the capability to image whole organs in a single rotation.

Integrations
EHR Not specified
Specialties Cardiology, Interventional Radiology, Radiology

What the Web Says

The Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System, including its INSIGHT and PRISM editions, is a highly regarded CT scanner by physicians for its advanced imaging capabilities and AI-assisted workflows. It is designed to provide high-quality images at low radiation doses, enhancing diagnostic confidence across various applications. The system emphasizes patient comfort and operational efficiency through its design and automated features.

Overall: Positive

Strengths

  • High image quality and improved resolution, even at low doses, due to technologies like AiCE and PIQE Deep Learning Reconstruction.
  • Reduced radiation dose through features like SilverBeam filter, beneficial for all patients, especially children and those requiring frequent scans.
  • AI-assisted workflow automation (INSTINX and New User Experience) for increased efficiency, consistency, and ease of use, even for new operators.
  • Fast acquisitions and whole-organ imaging in a single rotation, enabling quick head-to-toe scans.
  • Enhanced diagnostic confidence due to more detailed images and data, aiding in informed decision-making.
  • Patient-centric design with a wide, open, and low gantry bore (78-80 cm) and high table weight capacity, improving comfort and access.

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra.
  • Some features like PIQE 1024, CLEAR Motion, and Tech Assist Lateral Slide are optional and may not be included in all configurations.

Based on reviews from: Canon Medical Systems USA, Canon Medical Systems UK, AuntMinnie, Medical Buyer, YouTube, accessdata.fda.gov, BioSpace, Atlantis Worldwide, MyVisit (Canon Medical), Xplore Radiology

Last updated: 2026-07-19

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Frequently Asked Questions

The Aquilion ONE V10.0 (TSX-306A/3), and its subsequent editions like PRISM and INSIGHT, integrate AI for advanced image reconstruction, such as the Precise IQ Engine (PIQE) and Advanced intelligent Clear-IQ Engine (AiCE) Deep Learning Reconstruction (DLR) technologies. These AI features enhance image quality by reducing noise and improving spatial resolution at lower radiation doses, which directly benefits diagnostic accuracy, especially in cardiac, lung, and musculoskeletal imaging. Additionally, AI-assisted workflow automation, like INSTINX, streamlines operations through automated scan planning and protocol setup, improving efficiency and consistency across operators.
The AI components within the Aquilion ONE V10.0 (TSX-306A/3) and its editions have received necessary regulatory clearances, such as FDA 510(k) for features like Deep Learning Spectral CT and AI enhancements. The system is designed to operate within secure hospital networks, employing robust encryption and access controls to ensure compliance with patient data privacy regulations like HIPAA and GDPR. Vendors typically declare the accuracy and limitations of AI algorithms to support informed decision-making and safe integration into established systems.
The Aquilion ONE V10.0 (TSX-306A/3) with Deep Learning Spectral Imaging offers unique material characterization by acquiring nearly simultaneous CT images at distinct tube voltages, combined with DLR for excellent energy separation and low noise. This capability can provide advantages in specific clinical applications like cardiac imaging, where it enables whole-heart spectral images in one beat, and in differentiating tissues or quantifying elements, potentially surpassing conventional CT. While other high-end CTs also use AI for image quality, the Aquilion ONE's single-energy spectral acquisition with AI processing provides distinct benefits in tissue characterization that may be superior to some alternative modalities for specific indications.
The pricing for the Aquilion ONE V10.0 (TSX-306A/3) typically includes the capital expenditure for the hardware and initial software licenses. Ongoing costs generally involve annual service contracts that cover maintenance, technical support, and software updates, including enhancements to AI features. Physicians should clarify with the vendor regarding specific subscription models for future AI upgrades or advanced analytics tools, as these can vary.
AI algorithms, including those in the Aquilion ONE V10.0 (TSX-306A/3), are trained on specific datasets, which can introduce biases if not sufficiently diverse. Performance may vary with extreme patient body habitus, unusual pathologies, or specific implant types not adequately represented in the training data. It is crucial for physicians to understand that AI is a supportive tool, not a replacement for clinical judgment, and to be aware of its validated operating parameters and potential variations in performance across diverse patient populations.
The AI functionality of the Aquilion ONE V10.0 (TSX-306A/3) is designed for seamless integration into existing radiology workflows, often processing data directly at the scanner or sending processed images to PACS/RIS. Optimal performance typically requires a robust hospital network, sufficient storage, and compatibility with existing IT infrastructure, supporting interoperability standards like DICOM and HL7. AI-assisted workflow automation, such as INSTINX, aims to simplify operations and reduce manual steps, enhancing overall efficiency.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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