Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System

by Canon Medical Systems Corporation  · Based in Japan → — Empowering Physicians with Deep Intelligence for Confident Diagnosis through Advanced CT Imaging.
Cardiology Radiology
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Regulatory Status Disclosed

Overview

The Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System by Canon Medical Systems Corporation is a whole-body multi-slice helical CT scanner designed to provide advanced diagnostic capabilities. This system integrates artificial intelligence (AI) technology to enhance conventional and spectral CT imaging, offering intelligent clinical insights to support physicians in making more informed decisions across the patient’s care cycle.

Key to its performance are technologies like the Advanced intelligent Clear-IQ Engine (AiCE) Deep Learning Reconstruction (DLR), which uses deep learning to distinguish true signal from noise, delivering sharp, clear images at fast speeds. The Deep Learning Spectral Imaging capabilities enable physicians to achieve more confident diagnoses by harnessing rapid kV switching with patient-specific mA modulation, full field of view acquisition, and 16cm of coverage, combined with DLR for excellent energy separation and low-noise properties. The system is capable of acquiring and displaying cross-sectional volumes of the whole body, including organs like the brain, heart, and pancreas, in a single rotation.

Further enhancements in related editions, which build upon the V10.4, include the Precise IQ Engine (PIQE) for super-resolution Deep Learning Reconstruction, improving spatial resolution for cardiac applications and reducing noise. The system also features raw data motion correction (CLEAR Motion) for improved diagnostic confidence in cardiac imaging, and an intuitive user experience with AI-assisted workflow automation, such as automatic scan planning and Anatomical Landmark Detection (ALD). The SilverBeam Filter contributes to ultra-low dose scanning, particularly for applications like lung cancer screening.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Advanced intelligent Clear-IQ Engine (AiCE) Deep Learning Reconstruction (DLR)
  • Deep Learning Spectral Imaging with rapid kV switching
  • Precise IQ Engine (PIQE) Super Resolution DLR (in later versions building on V10.4)
  • Raw data motion correction (CLEAR Motion) for cardiac imaging
  • AI-assisted workflow automation (INSTINX, Anatomical Landmark Detection)
  • 16cm wide-area detector for single-rotation whole-organ imaging
  • 0.241 second rotation speed for ultra-fast acquisitions
  • SilverBeam Filter for ultra-low dose scanning
  • 80 cm gantry bore and low table height for patient comfort and access
  • Integrated end-to-end workflow

Use Cases

  • Whole-body cross-sectional imaging (brain, heart, lung, musculoskeletal, abdomen, pelvis, inner ear, extremities)
  • Enhanced diagnostic confidence through spectral insights
  • Cardiac imaging, including in-stent visualization and evaluation of calcified coronary arteries
  • Lung cancer screening with ultra-low dose
  • Interventional procedures with CT Fluoroscopy
  • Material composition analysis of organs, tissues, and contrast materials

What Physicians Need to Know

DICOM Support & Standards
The Aquilion ONE (TSX-306A/3) V10.4, like other Canon Medical CT systems, provides comprehensive DICOM support, with detailed Conformance Statements available to facilitate compatibility and integration within DICOM-compliant hospital networks.
PACS Integration Method
Offers seamless PACS integration, allowing automatic transfer of spectral data, including monochromatic volumes, iodine maps, and virtual non-contrast (VNC) images. Spectral analysis and material differentiation evaluations can be launched directly from PACS using integrated Vitrea Advanced Visualization software.
Reading Room Workflow Impact
Designed for an integrated, end-to-end workflow that is easy to use and can be incorporated into routine protocols. Deep Learning Spectral CT automatically generates various image types (monochromatic, material-specific, iodine maps) without additional technologist effort, delivering a rich array of diagnostic information directly to the reading station. Acquisition timing and reconstruction speed for spectral imaging are comparable to single-energy examinations.
AI Model Architecture (deep learning approach)
Integrates multiple Deep Learning Reconstruction (DLR) algorithms: Advanced intelligent Clear-IQ Engine (AiCE) for noise reduction and enhanced anatomical resolution across the whole body; Precise IQ Engine (PIQE) for super-resolution, improving spatial resolution and noise reduction, especially for cardiac, abdomen, pelvis, and lung applications; and Deep Learning Spectral Reconstruction for excellent energy separation and low-noise spectral imaging. CLEAR Motion, a DLR method, is also used for motion artifact reduction.
Processing Speed (per study)
Capable of acquiring whole-heart spectral images in a single beat, with an ultra-fast 0.24-second rotation speed and 16 cm wide-area detector, enabling full organ coverage in one rotation. Spectral image reconstruction speed is nearly identical to single-energy examinations.
FDA Clearance Pathway (510k/De Novo)
The Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System, along with its subsequent versions and related editions (PRISM, INSIGHT), has received 510(k) clearance from the U.S. FDA. Key AI features like AiCE and Deep Learning Spectral Imaging also received 510(k) clearance.
Supported Modalities (CT/MRI/X-ray/US)
This is a Computed Tomography (CT) system, with spectral imaging capabilities specifically for CT. While associated Vitrea software can process data from various modalities, the Aquilion ONE itself is a CT scanner.
Sensitivity & Specificity Data
The system's AI and spectral features (AiCE, PIQE, Deep Learning Spectral Reconstruction) are designed to improve image quality, reduce noise, enhance anatomical resolution, and enable better delineation of small structures. Spectral imaging facilitates material differentiation (e.g., uric acid vs. non-uric acid stones, iodine uptake, effective Z, electron density maps) and improved assessment of lumen stenosis in calcified plaque, contributing to more confident diagnoses. Performance testing has demonstrated equivalent or improved image quality metrics compared to predicate devices.
RSNA/ACR Validation
Canon Medical Systems has actively showcased the Aquilion ONE / PRISM Edition and its AI and spectral capabilities at major conferences, including RSNA (e.g., RSNA 2020, 2024, 2025). The Aquilion ONE / INSIGHT Edition was recognized as the 2024 Best New Radiology Device by the Minnies Awards at RSNA 2024.
Physician Tip

Leverage the integrated Deep Learning Reconstruction (AiCE, PIQE, Deep Learning Spectral Reconstruction) to achieve superior image quality with reduced noise and enhanced spatial resolution, particularly beneficial for complex cases like cardiac imaging with calcified plaques or subtle lesion detection. Utilize the spectral imaging capabilities for advanced tissue characterization, such as differentiating kidney stone composition (uric acid vs. non-uric acid) and quantifying iodine uptake, which can significantly impact diagnosis and treatment planning. The automated workflow and direct PACS integration of spectral data streamline the reading process, allowing for efficient access to comprehensive diagnostic information. For interventional procedures, the fast acquisition and AI-assisted workflow can enhance precision and efficiency.

The Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System is designed for seamless integration into existing hospital IT infrastructure through standard DICOM protocols. Its spectral data, including monochromatic images and iodine maps, are automatically transferred to PACS. Further advanced visualization and quantitative analysis of spectral data are facilitated by integration with Canon's Vitrea Advanced Visualization software, which can be scaled from a single workstation to a hospital-wide network.

Details

Category Radiology & Imaging AI
Pricing Contact vendor for pricing.
  • Contact vendor for new system pricing
  • Used/refurbished units of Aquilion ONE have been observed between $240,000 and $782,450
DeploymentOn-premise
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System received 510(k) premarket clearance (K203225) from the U.S. FDA on March 24, 2021, for whole-body cross-sectional imaging, including spectral capabilities for various anatomical locations.
Integrations
EHR Not specified
Specialties Cardiology, Radiology

What the Web Says

The Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System, often referred to as the Aquilion ONE / PRISM Edition or INSIGHT Edition, is a highly regarded CT scanner by physicians. It is praised for its advanced AI-assisted workflows, deep learning reconstruction technologies, and spectral imaging capabilities, which contribute to high-quality images and reduced radiation doses. The system is considered versatile, capable of performing a wide range of exams, including cardiac, neurological, and musculoskeletal imaging, with efficiency and precision.

Overall: Positive

Strengths

  • High-quality images with improved spatial resolution and reduced noise, even for complex cases like in-stent visualization.
  • AI-assisted workflow automation, such as INSTINX and Anatomic Landmark Detection (ALD), which reduces workflow steps and ensures consistent results.
  • Deep Learning Reconstruction (DLR) technologies (AiCE, PIQE, CLEAR Motion) enhance image quality, reduce noise, and correct for motion, particularly beneficial for cardiac and lung imaging.
  • Spectral imaging capabilities provide intelligent clinical insights and can decrease iodine load.
  • Ultra-low dose scanning with features like SilverBeam filter, significantly reducing patient radiation exposure.
  • Wide-area detector (16 cm) allows for whole-organ scanning in a single rotation, enabling fast and comprehensive exams, especially for the heart and brain.

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra.
  • The system is advanced and likely represents a significant investment, though cost was not explicitly mentioned as a 'con' in the provided snippets.

Based on reviews from: Canon Medical Systems USA, DirectMed Imaging, YouTube (Canon Medical Systems), BioSpace, Imaging Technology News, Atlantis Worldwide, Xplore Radiology Narellan, Canon Global, accessdata.fda.gov

Last updated: 2026-07-18

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Press & Coverage

Innolitics
Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System Cleared Traditional
The Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System received FDA clearance on March 24, 2021. This system is a whole-body multi-slice helical CT scanner.
2021-03
U.S. Food & Drug Administration (FDA)
FDA 510(k) Premarket Notification K203225
This FDA document details the 510(k) premarket notification for the Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System, outlining its device description, indications for use, and substantial equivalence to a predicate device. The submission includes cybersecurity documentation and testing in accordance with IEC standards.
2021-03
Medical Device Watch
Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
The Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System is an FDA-cleared radiology AI listing for CT/CTA. It was cleared as a Class 2 device.
2021-03
U.S. Food & Drug Administration (FDA)
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea - FDA 510(k) Premarket Notification
A later version, Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, was found substantially equivalent to the V10.4 version, incorporating changes like PIQE (Precise IQ Engine) for improved cardiac applications.
2022-06
FDA.report
CANON INC. FDA Filings
Canon Inc. has several FDA filings, including the Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System, which was cleared on March 24, 2021.
2021-03

Videos

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Frequently Asked Questions

The Aquilion ONE V10.4 system leverages AI through technologies like Advanced intelligent Clear-IQ Engine (AiCE) and Precise IQ Engine (PIQE) Deep Learning Reconstruction (DLR) to significantly reduce image noise and improve spatial resolution, leading to sharper, clearer images for enhanced diagnostic confidence across various applications including cardiac, body, and lung imaging. Additionally, AI-assisted workflow automation, such as INSTINX, streamlines scan planning and patient positioning, optimizing efficiency and consistency in clinical practice.
The AI components within Canon Medical's Aquilion ONE systems, including versions like the Aquilion ONE / INSIGHT Edition and Aquilion ONE / PRISM Edition, have received FDA 510(k) clearance, indicating compliance with U.S. medical device regulations. The FDA regulates AI as a medical device if it's intended for diagnosis, treatment, or prevention of disease, requiring premarket review and adherence to Quality System Regulation (QSR), which includes design controls and risk management. Cybersecurity documentation is also a part of the FDA submission process for these devices. While specific details on HIPAA and GDPR adherence for this exact version weren't explicitly found, medical devices operating in healthcare are generally expected to comply with relevant data privacy regulations.
Key competitors offering advanced spectral CT systems with AI capabilities include Philips with its Spectral CT Verida, GE HealthCare with systems like the Revolution Apex featuring Edison DLR and photon-counting CT, and Siemens Healthineers with photon-counting CT and AI-Rad Companion. These alternatives also focus on improving image quality, reducing dose, and enhancing workflow through AI-powered reconstruction and automation.
The pricing for a Canon-Toshiba Aquilion ONE system can vary significantly, with used or refurbished units ranging from approximately $240,000 to $782,450, and an average around $455,817 based on market listings. New premium CT systems from competitors have been noted to cost between 1 million and 2 million euros. While specific pricing for AI features or software updates for the V10.4 wasn't detailed, advanced AI functionalities and ongoing software support are typically factored into the overall cost or offered as separate packages.
While AI in the Aquilion ONE V10.4 system enhances image quality and workflow, physicians should be aware of general limitations inherent in AI diagnostic tools. These include potential biases from insufficient or non-representative training data, which can affect the AI's performance in diverse real-world clinical settings. Additionally, AI primarily serves to highlight patterns and flag cases for human review, rather than making independent diagnoses or treatment decisions. For spectral CT specifically, challenges can arise from a lack of comprehensive understanding or training on how to interpret the extensive additional information provided, and time constraints in high-throughput environments for detailed review.
Canon Medical Systems includes cybersecurity documentation as part of its FDA submissions for devices like the Aquilion ONE, indicating measures to protect patient data. While specific details on cloud-based processing for the V10.4 were not found, medical device manufacturers are generally required to adhere to stringent data privacy regulations like HIPAA and GDPR. These regulations mandate robust security protocols to safeguard sensitive patient information, whether data is processed locally or in the cloud.
The Aquilion ONE V10.4 system's AI, such as AiCE and PIQE, is designed to provide optimized image reconstruction across various applications like cardiac, body, and lung imaging. While the system offers AI-assisted workflow automation for consistent results, the ability for physicians to directly customize or fine-tune the underlying AI algorithms for specific clinical protocols or patient populations beyond the pre-defined settings is typically limited in commercial medical devices. However, clinicians can often customize optimal image de-noising according to their preferences with AI-based reconstruction engines.

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