Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System

by Canon Medical Systems  · Based in Japan → — Innovating Medical Imaging with AI-Powered CT and Advanced Visualization.
Cardiology Oncology Radiology
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Regulatory Status Disclosed

Overview

The ‘Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System’ is a state-of-the-art Computed Tomography (CT) scanner, and ‘Vitrea Software Package’ refers to Vitrea Advanced Visualization software. It is crucial to clarify that this product is a medical imaging system and associated advanced visualization software, and **not** an AI tool for a physician directory as initially suggested in the prompt. The system is designed for comprehensive diagnostic imaging across various medical specialties.

The Aquilion ONE / PRISM Edition (which includes the TSX-306A/3 model and V10.12 software with spectral imaging) from Canon Medical Systems integrates advanced artificial intelligence (AI) technologies to enhance image quality, optimize workflow, and provide intelligent clinical insights. Key AI components include Deep Learning Reconstruction (DLR) technologies like AiCE (Advanced intelligent Clear-IQ Engine) and PIQE (Precise IQ Engine), which are trained to distinguish true signal from noise, delivering sharp, clear, and distinct images at fast speeds. AI-assisted workflow automation is also a significant feature, designed to improve consistency, efficiency, and ease of use.

Vitrea Advanced Visualization, developed by Vital Images (a Canon Inc. company), is a multi-modality, vendor-agnostic software suite that offers comprehensive applications for 2D, 3D, and 4D advanced visualization and analysis of clinical data from various modalities (CT, MR, XA, PET, US, SPECT). It provides advanced imaging tools, such as in-suite 3D viewing and semi-automated measurements, to assist physicians in planning procedures and treating patients. Vitrea also incorporates AI workflow automation and quantitative image analysis to support confident diagnosis and risk assessment.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Spectral Imaging System with rapid kV switching for material composition analysis
  • Deep Learning Reconstruction (DLR) with AiCE and PIQE for enhanced image quality and noise reduction
  • AI-assisted workflow automation for improved consistency and efficiency
  • Wide-area CT detector (16 cm) for whole organ imaging in a single rotation
  • Ultra-low dose scanning capabilities with technologies like SilverBeam Filter
  • Multi-modality advanced visualization and analysis (Vitrea)
  • 2D, 3D, and 4D advanced visualization for clinical data
  • Vendor-agnostic advanced visualization platform (Vitrea)
  • Global Illumination for photorealistic 3D/4D rendering (Vitrea)
  • Quantitative image analysis for confident diagnosis and risk assessment (Vitrea)

Use Cases

  • Comprehensive diagnostic imaging (head-to-toe)
  • Cardiac imaging and analysis, including in-stent visualization
  • Stroke assessment and brain perfusion analysis
  • Oncology imaging and follow-up
  • Musculoskeletal imaging and dynamic volume CT
  • Vascular analysis and angiography

What Physicians Need to Know

DICOM Support & Standards
Full DICOM compliance (Aquilion ONE TSX-306A, V10.4 or later) with available conformance statements. Adheres to ISO 13485 and relevant IEC/NEMA standards (e.g., IEC60601, NEMA XR-25/26/29) for medical device safety and performance.
PACS Integration Method
Seamless integration with PACS via Vitrea Advanced Visualization software for multi-dimensional image processing, review, analysis, and communication. Supports automatic transfer of Deep Learning Spectral images (monochromatic volumes, iodine maps, VNC) and direct launch of spectral analysis from PACS.
Reading Room Workflow Impact
Features AI-assisted workflow automation (INSTINX) for improved consistency, efficiency, and reduced manual steps. Includes AI-assisted 3D Landmark Scan and Anatomical Landmark Detection (ALD) for automatic, accurate scan planning. Offers an intuitive user interface and rapid patient positioning, contributing to faster stroke assessment (under 5 minutes).
AI Model Architecture (deep learning approach)
Incorporates Deep Convolutional Neural Network (DCNN) methods for: AiCE (noise reduction across various body regions), PIQE (Precise IQ Engine for Super Resolution 1024 matrix images, enhanced spatial resolution, and noise reduction in cardiac, abdomen, pelvis, and lung), Deep Learning Spectral Reconstruction (for energy separation and low-noise spectral imaging), and CLEAR Motion Cardiac (AI-enabled motion correction for cardiac CT).
Processing Speed (per study)
Achieves ultra-fast 0.24-second rotation speed for wide-area 16 cm CT, enabling whole-organ coverage and one-beat cardiac acquisitions. Facilitates head-to-toe scans in seconds and comprehensive stroke evaluations in under 5 minutes.
FDA Clearance Pathway (510k/De Novo)
Received 510(k) clearance (K213504) on June 16, 2022, as a modification of an existing medical device, demonstrating substantial equivalence to predicate devices.
Supported Modalities
Primarily a whole-body multi-slice helical CT scanner. Its Vitrea software package supports processing and analysis of images from various modalities including CT, X-ray angiography (XA), MRI, and Ultrasound (US), with specific applications like US Cardiac Fusion.
Sensitivity & Specificity Data
Phantom studies demonstrated equivalent or improved performance in image quality metrics (e.g., CT Number Accuracy, Low Contrast Detectability). Specific low contrast detectability: 2 mm at 0.3% (AIDR3D/AiCE). PIQE offers 45% noise reduction and improved spatial resolution without loss of low contrast detectability. SilverBeam with AiCE provides high-quality, low-noise lung cancer screening images at doses comparable to chest X-rays. Achieves 97% accuracy in scan range planning with ALD.
RSNA/ACR Validation
Canon Medical Systems consistently showcases Aquilion ONE innovations and AI enhancements (PIQE, SilverBeam, CLEAR Motion Cardiac) at RSNA. The Aquilion ONE / INSIGHT Edition was recognized as the 2024 Best New Radiology Device by the Minnies Awards at RSNA 2024.
Physician Tip

Leverage AI-powered reconstruction (AiCE, PIQE, Deep Learning Spectral) for superior image quality, reduced noise, enhanced spatial resolution, and optimized dose across various studies, particularly for cardiac, lung, and spectral applications. Utilize the spectral imaging capabilities for advanced material characterization, stone analysis, and efficient contrast media usage. Embrace the AI-assisted workflow features (INSTINX, ALD) to streamline scan planning, improve consistency, and potentially reduce examination times. For challenging cardiac cases, the one-beat acquisition and AI-enabled motion correction (CLEAR Motion Cardiac) can significantly improve diagnostic confidence. The integrated Vitrea Advanced Visualization software allows for comprehensive post-processing and analysis directly from PACS, enabling deeper clinical insights.

The Aquilion ONE (TSX-306A/3) V10.12 ensures robust interoperability through full DICOM compliance, facilitating seamless integration with existing PACS and hospital networks. Its advanced visualization capabilities are significantly enhanced by tight integration with Vitrea software, allowing for direct launch of sophisticated spectral analysis and fusion imaging applications from the PACS environment. The AI-driven workflow automation tools are designed to integrate smoothly into the radiology workflow, aiming to minimize manual intervention and promote consistent, high-quality imaging across different operators and studies.

Details

Category Radiology & Imaging AI
Pricing Contact vendor for pricing details
  • Enterprise sales model; pricing varies based on configuration, deployment, and included applications
DeploymentWorkstation, Extend (3-user), Enterprise (scalable thin-client access, single server for up to 6 concurrent users) for Vitrea.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

The Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System received FDA 510(k) premarket clearance (K213504) on June 16, 2022, as a whole body multi-slice helical CT scanner. It is classified as a Class II medical device (21 CFR §892.1750).
Integrations
EHR Not specified
Specialties Cardiology, Oncology, Radiology

What the Web Says

The Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System is a whole-body multi-slice helical CT scanner from Canon Medical Systems, designed for specialized studies and whole-organ imaging in a single rotation. It incorporates advanced technologies like Deep Learning Reconstruction (DLR) with AiCE and PIQE, and a spectral imaging system for enhanced image quality and dose reduction. The system aims to improve diagnostic confidence, streamline workflow, and enhance patient experience.

Overall: Positive

Strengths

  • Deep Learning Reconstruction (DLR) with AiCE and PIQE for improved image quality, noise reduction, and enhanced spatial resolution across various applications (brain, cardiac, lung, abdomen, pelvis, extremities).
  • Spectral imaging capabilities for more routine spectral imaging, providing excellent energy separation and low-noise properties for detailed analysis and definitive diagnoses.
  • Fast acquisitions and whole-organ imaging with wide-area CT (16 cm z-axis coverage), allowing for single-rotation scans of entire organs like the brain and heart.
  • Optimized workflow with a new intuitive user interface and AI-assisted automation (e.g., INSTINX, 3D Landmark Scan, Anatomical Landmark Detection) for enhanced consistency, efficiency, and ease of use.
  • Ultra-low dose scanning enabled by technologies like SilverBeam Filter and iterative reconstruction algorithms (FIRST), balancing image quality and radiation dose.
  • Wide, open, and low system design (78 cm gantry bore, 33 cm low table height) to enhance patient access, comfort, and safety, accommodating bariatric patients.

Limitations

  • Some users of older Toshiba Aquilion CT scanners (Canon Medical Systems was formerly Toshiba Medical Systems) have reported difficulties with complex scanning protocols and combining separate scan phases, leading to frustration with the user interface and unpredictable results.
  • Difficulty in figuring out advanced reconstruction settings and a reliance on trial-and-error for optimal results on older Aquilion models.
  • Potential for system downtime due to power surges or fluctuations causing gantry and computer desynchronization, requiring a full system restart (reported on a related Aquilion model).
  • Automated positioning features may be perceived as a gimmick and not widely utilized by experienced technologists.
  • Lack of specific detailed reviews from healthcare IT or dedicated tech reviewers for this exact version (V10.12 with Spectral Imaging System) on platforms like G2 or Capterra, making it challenging to assess broader industry sentiment beyond clinical applications.

Based on reviews from: accessdata.fda.gov, Canon Medical Systems USA, Medical Buyer, AuntMinnie, Reddit, Innolitics, Canon Medical Systems UK, Universal Systems Diagnostic Inc, Canon Medical

Last updated: 2026-07-19

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Press & Coverage

U.S. Food & Drug Administration (FDA)
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea - accessdata.fda.gov
This regulatory announcement details the FDA's 510(k) premarket clearance for the Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A, granted to Canon Medical Systems Corporation on June 16, 2022. The document describes the device as a whole-body multi-slice helical CT scanner with spectral imaging capabilities, including new features like PIQE, brain imaging for Spectral Imaging System, SilverBeam Filter, and an intuitive user interface.
2022-06
U.S. Food & Drug Administration (FDA)
April 2, 2024 Canon Medical Systems Corporation Orlando Tadeo Jr Sr. Manager, Regulatory Affairs Canon Medical Systems, USA - accessdata.fda.gov
This FDA document from April 2, 2024, discusses the substantial equivalence of the Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System to the Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System (K213504). It highlights the continued evolution of the Aquilion ONE line with new reconstruction systems while maintaining the same intended use for whole-body cross-sectional imaging.
2024-04
Scribd (reposting FDA information)
Artificial Intelligence and Machine Learning (AIML) - Enabled Medical Devices FDA - Scribd
This document, likely a compilation of FDA data, lists the Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System as an Artificial Intelligence and Machine Learning (AIML)-enabled medical device. It indicates Canon Medical Systems Corporation as the manufacturer and categorizes it under Radiology.
unknown
Physician AI Tools
SwiftMR vs Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System
This comparison article from Physician AI Tools evaluates SwiftMR (MRI) against the Aquilion ONE with Spectral Imaging System (CT), highlighting their respective innovations in AI for image reconstruction and workflow. The Aquilion ONE is noted for its Deep Learning Reconstruction (DLR) with AiCE and PIQE for enhanced image quality and noise reduction, as well as spectral imaging for material composition analysis.
2026-07
Physician AI Tools
Aplio a550 vs Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System
This comparison focuses on the Aplio a550 (ultrasound) and the Aquilion ONE with Spectral Imaging System (CT), emphasizing the Aquilion ONE's strengths in comprehensive anatomical imaging, material composition analysis, and AI-powered workflow automation for cardiology and oncology. It highlights the system's superior image quality with ultra-low dose capabilities and advanced 2D, 3D, and 4D visualization.
2026-07
Physician AI Tools
CT/CTA workflow radiology AI tools | Buyer shortlist
This buyer's shortlist of CT/CTA workflow radiology AI tools includes the Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A, from Canon Medical Systems Corporation. It notes the FDA clearance date of June 16, 2022, and categorizes it under image analysis/processing for CT/CTA modalities.
2022-06
Constat
Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System (K203225) - Constat
Constat, a platform for FDA/CMS data, references the Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System (K213504) as a newer 510(k) clearance for the same device line, with a decision date of June 16, 2022. It also mentions the inclusion of AiCE, a noise reduction algorithm utilizing Deep Convolutional Neural Network methods.
2026-07
U.S. Food & Drug Administration (FDA)
K213504 - 510(k) Premarket Notification - FDA
This is the direct FDA 510(k) Premarket Notification page for the Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A. It confirms Canon Medical Systems Corporation as the applicant and lists the regulation number and product codes.
2026-05

Videos

Product demos, reviews, and walkthroughs for Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System.

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Frequently Asked Questions

The Aquilion ONE V10.12 system incorporates AI technologies like Advanced intelligent Clear-IQ Engine (AiCE) and Precise IQ Engine (PIQE) Deep Learning Reconstruction (DLR) to enhance image quality by reducing noise and improving spatial resolution, particularly for cardiac, brain, lung, and musculoskeletal applications. These AI features aim to streamline post-processing and provide clearer images for more confident diagnoses.
The Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, including its integrated AI features like PIQE and AiCE, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance indicates that the device is substantially equivalent to legally marketed predicate devices and is considered safe and effective for its intended use.
While the search results highlight the benefits of the AI algorithms, specific limitations or biases are not explicitly detailed. Generally, AI algorithms are trained on vast datasets, and their performance can be influenced by the diversity and representativeness of that data. Manufacturers typically mitigate potential biases through rigorous validation, continuous improvement, and by emphasizing that AI serves as an assistive tool for physician interpretation.
The Aquilion ONE V10.12 leverages its unique single-energy detector spectral capabilities with Deep Learning Spectral Reconstruction, combined with AiCE and PIQE DLR, to provide excellent energy separation and low-noise properties. Competing systems may utilize different spectral acquisition methods, such as dual-energy, with AI optimized for their specific data types, leading to varied strengths across clinical applications.
The search results indicate that features like PIQE and Deep Learning Spectral imaging are often presented as integral components or options within the Aquilion ONE / PRISM Edition and INSIGHT Edition, which are related to the V10.12 system. While some core AI enhancements might be standard, specific advanced AI applications or modules could be optional, potentially affecting the overall cost of ownership.
The FDA clearance documentation for the Aquilion ONE V10.12 mentions adherence to cybersecurity documentation per FDA guidance, indicating that data security is a considered aspect of the device's design and regulatory approval. Medical devices are generally expected to comply with regulations like HIPAA and GDPR, employing encryption and secure processing to protect patient data.
The FDA clearance documents and product descriptions highlight that AI features like PIQE and AiCE are designed to improve image quality, reduce noise, and enhance spatial resolution, which are foundational for diagnostic efficacy. PIQE, for example, is noted for improved in-stent visualization and reduced noise in cardiac applications without additional dose. Manufacturers typically provide clinical validation studies to support these claims.

Compare Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System

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SwiftMR vs Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System
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SwiftMR is an AI-powered software solution that enhances existing MRI scanner capabilities by reducing scan times and improving image quality across various vendors. In contrast, the Aquilion ONE…
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CINA-CSpine vs Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System
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Tool A, CINA-CSpine, is an AI-powered software designed for the rapid detection and triage of acute cervical spine fractures on existing CT scans. In contrast, Tool B, the…
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Aplio a550 vs Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System
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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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