Aquilion ONE (TSX-305A/6) V8.9 with AiCE

by Canon Medical Systems Corporation  · Based in Japan → — Empowers Physicians with Deep Intelligence to Enable Routine Confident Diagnosis.
Cardiology Pulmonology Radiology
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Regulatory Status Disclosed

Overview

The Aquilion ONE (TSX-305A/6) V8.9 with AiCE from Canon Medical Systems Corporation is a whole-body multi-slice helical Computed Tomography (CT) scanner that integrates advanced artificial intelligence (AI) technology to redefine diagnostic imaging. At its core is the Advanced intelligent Clear-IQ Engine (AiCE), an innovative Deep Learning Reconstruction (DLR) method built on an Artificial Intelligent Neural Network. AiCE is trained using vast amounts of high-quality image data to differentiate true signal from noise, effectively suppressing noise while enhancing signal. This results in exceptionally sharp, clear, and distinct images with improved spatial resolution and low-contrast detectability, often at significantly reduced radiation doses compared to traditional methods.

The system is designed to maximize conventional and spectral CT capabilities and automate workflows, providing intelligent clinical insights to assist physicians in making more informed decisions across the patient’s care cycle. It offers a fully integrated, end-to-end workflow that is easy to use and can be incorporated into routine protocols, transforming clinical confidence and patient experience.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Advanced intelligent Clear-IQ Engine (AiCE) Deep Learning Reconstruction (DLR) for noise reduction and signal enhancement
  • Sharp, clear, and distinct images with improved spatial resolution and low-contrast detectability
  • Reduced radiation dose for various examinations (e.g., 20% for body, 40% for cardiac)
  • AI-assisted workflow automation for improved consistency and efficiency (e.g., 3D Landmark Scanogram with Anatomical Landmark Detection)
  • Wide-area CT with 16 cm z-axis coverage and 320 detector rows for rapid acquisition
  • Deep Learning Spectral Imaging (available on PRISM Edition) for confident diagnosis through spectral insights
  • Precise IQ Engine (PIQE) 1024 DLR for super resolution imaging (available on INSIGHT/PRISM Editions)
  • SilverBeam Filter for ultra-low dose lung cancer screening and MSK imaging
  • Enhanced user interface with compact scan control system and 27-inch 4K monitor
  • Tech Assist Lateral Slide for automated patient positioning and improved access

Use Cases

  • Whole-body CT imaging with enhanced anatomical resolution
  • Cardiac imaging, including one-beat cardiac CT, stent visualization, and calcification assessment
  • Neurological imaging for brain, stroke evaluation, perfusion analysis, and AVMs
  • Oncology applications such as metastatic evaluation and lesion detection
  • Ultra-low dose lung cancer screening
  • Musculoskeletal (MSK) imaging
  • Interventional procedures with CT Fluoroscopy (CTF) interface

What Physicians Need to Know

DICOM Support & Standards
The Aquilion ONE (TSX-305A/6) V8.9 with AiCE adheres to open network standards, complying with DICOM and IHE standards for seamless communication within hospital networks. It supports DICOM network and media storage services, including storage, query/retrieve, workflow management, and print services, as well as CD, DVD, and DVD-RAM storage. Secure DICOM communication with a TLS option is also supported, though it is deactivated by default.
PACS Integration Method
The system facilitates direct delivery of images to reading stations for easy review. It supports automatic transfers of monochromatic volumes, iodine maps, and VNC images to PACS with Deep Learning Spectral. Furthermore, spectral material differentiation and characterization evaluations can be launched directly from PACS through integration with Vitrea Advanced Visualization software.
Reading Room Workflow Impact
AiCE integrates AI-assisted workflow automation (INSTINX) to enhance efficiency, reduce workflow steps by 40%, and improve user satisfaction. It features an intuitive, easy-to-learn interface and AI-assisted 3D Landmark Scan with Anatomical Landmark Detection (ALD) for consistent and accurate scan range planning, boasting 97% accuracy. The end-to-end workflow is designed for seamless integration into routine practice.
AI Model Architecture (deep learning approach)
AiCE (Advanced intelligent Clear-IQ Engine) is a Deep Learning Reconstruction (DLR) technology that utilizes a Deep Convolutional Neural Network (DCNN). It is trained on vast amounts of high-quality image data, often derived from advanced Model-Based Iterative Reconstruction (MBIR) algorithms, to differentiate true signal from noise, suppress noise, and enhance signal. The system incorporates dedicated high-performance hardware, including eight powerful graphics cards, to optimize AiCE for 640 slices, with computing power approaching that of IBM's Watson.
Processing Speed (per study)
AiCE reconstructs CT images with improved spatial resolution three to five times faster than traditional MBIR, delivering sharp, clear, and distinct images at high speeds. The Aquilion ONE / INSIGHT Edition boasts an ultra-fast 0.24-second rotation speed for wide-area CT, enabling head-to-toe scans in seconds. Comprehensive stroke evaluations, including whole-brain perfusion and 4D digital subtraction angiography, can be completed in as little as one minute, with flow and perfusion defect analysis available in under five minutes.
FDA Clearance Pathway (510k/De Novo)
AiCE has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Specifically, the Aquilion ONE / PRISM Edition, which incorporates AiCE and Deep Learning Spectral capabilities, received 510(k) clearance in February 2020. AiCE was initially cleared on the Aquilion Precision and Aquilion ONE / Genesis Edition CT systems.
Supported Modalities
The Aquilion ONE (TSX-305A/6) V8.9 with AiCE is a whole-body multi-slice helical CT scanner. AiCE is a CT reconstruction technology that provides enhanced anatomical resolution across various body regions, including the abdomen, pelvis, lung, cardiac, brain, inner ear, extremities, and musculoskeletal systems.
Sensitivity & Specificity Data
AiCE delivers improved low-contrast detectability, noise reduction, and enhanced spatial resolution compared to hybrid iterative reconstruction. Clinical evaluations have shown a ~25% increase in SNR and CNR, alongside a ~20% dose reduction for body imaging and ~40% for cardiac examinations. The SilverBeam filter, when combined with AiCE, enables ultra-low dose lung cancer screening CTs at radiation levels comparable to a chest X-ray. A phantom study indicated that AiCE provided consistently higher detection performance (48% higher for a 6mm lumen diameter) and superior discrimination performance compared to AIDR-FC18. The Precise IQ Engine (PIQE) 1024 DLR, often used with AiCE, further maximizes detector resolution for super-resolution images with improved spatial resolution and 45% reduced noise for cardiac imaging.
RSNA/ACR Validation
Canon Medical Systems has actively showcased and launched its advanced CT technology, including AiCE, at the Radiological Society of North America (RSNA) annual meetings. For instance, the Aquilion ONE / INSIGHT Edition was launched at RSNA 2023, and AiCE technology was presented at RSNA in December 2019.
Physician Tip

Leverage AiCE for significant dose reduction without compromising image quality, especially beneficial for pediatric and screening protocols. Utilize the AI-assisted workflow automation (INSTINX) and Anatomical Landmark Detection (ALD) to streamline scan planning and improve consistency, freeing up time for patient interaction. For cardiac and complex vascular studies, combine AiCE with PIQE 1024 DLR and the ultra-fast rotation speed for superior image clarity and reduced motion artifacts, enabling more confident diagnoses. Explore the Deep Learning Spectral capabilities for advanced material characterization and analysis, directly integrated with PACS for efficient review.

The Aquilion ONE system with AiCE is designed for robust integration into existing radiology IT infrastructure through its adherence to DICOM and IHE standards. Seamless PACS integration allows for direct image transfer and advanced post-processing via Vitrea Advanced Visualization software. The system's automated workflow features are built to complement and enhance current reading room practices, ensuring a smooth transition and improved operational efficiency.

Details

Category Radiology & Imaging AI
Pricing Contact vendor
  • Not publicly available
  • Pricing is typically provided upon direct inquiry to Canon Medical Systems Corporation
DeploymentOn-premise (CT scanner hardware)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status K183046 AI-estimated

The Aquilion ONE (TSX-305A/6) V8.9 with AiCE received 510(k) clearance on June 12, 2019. It is cleared as a whole-body multi-slice helical CT scanner, with AiCE as a reconstruction algorithm that utilizes Deep Convolutional Neural Network methods to reduce image noise and improve image quality, deemed substantially equivalent to a predicate device.
Integrations
EHR Not specified
Specialties Cardiology, Pulmonology, Radiology

What the Web Says

The Aquilion ONE (TSX-305A/6) V8.9 with AiCE is a multi-slice helical CT scanner that utilizes Deep Learning Reconstruction (DLR) technology to enhance image quality and reduce noise. Physicians and healthcare providers generally express positive opinions about its capabilities, particularly regarding improved low-contrast detectability, reduced radiation dose, and advanced cardiac imaging. The system aims to streamline workflow and provide accurate diagnoses across various medical specialties.

Overall: Positive

Strengths

  • Improved low-contrast detectability.
  • Reduced image noise.
  • Potential for lower radiation dose.
  • Whole organ imaging in a single rotation.
  • Enhanced workflow and ease of use with AI-assisted automation.
  • Advanced cardiac imaging capabilities, including motion correction and high temporal resolution.

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra.
  • Bench testing only for clinical evidence in some aspects.

Based on reviews from: Innolitics (FDA 510(k) summary), Canon Medical Systems Europe, Canon Medical Systems USA, AuntMinnie, DirectMed Imaging, YouTube (Melbourne Heart Care, Canon Medical Systems Europe), accessdata.fda.gov, DAIC (Diagnostic and Interventional Cardiology), Tecnoimagen

Last updated: 2026-07-17

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Press & Coverage

Innolitics
Aquilion ONE (TSX-305A/6) V8.9 with AiCE (K183046) u2014 FDA 510(k) | Innolitics
The Aquilion ONE (TSX-305A/6) V8.9 with AiCE is a multi-slice helical CT scanner that received FDA 510(k) clearance on June 12, 2019. It utilizes AiCE, a deep convolutional neural network-based reconstruction algorithm, to produce high-quality, low-noise images for diagnostic assessment.
2019-06
Canon Medical Systems
Aquilion ONE (TSX-305A/6) V8.9 with AiCE | Canon Medical ...
This page confirms that the Aquilion ONE (TSX-305A/6) V8.9 with AiCE is an FDA-cleared radiology AI listing for CT/CTA, providing a resource to review FDA source links, workflow fields, and buyer-fit notes.
unknown
AIMS Press
The evolving landscape: Role of artificial intelligence in cancer detection - AIMS Press
Published in May 2024, this review highlights the Aquilion ONE (TSX-305A/6) V8.9 with AiCE as a device capable of capturing and displaying cross-sectional volumes of the entire body, including the head, with the ability to image whole organs in a single rotation, within the context of AI's role in cancer detection.
2024-05
PMC
Engineering with Biomedical Sciences Changing the Horizon of Healthcare-A Review - PMC
This review, accepted in July 2024, mentions the Aquilion ONE (TSX-305A/6) V8.9 with AiCE as a CT device from Canon Medical Systems Corporation, capable of whole-body imaging with a focus on capturing and displaying cross-sectional volumes of entire organs in a single rotation.
2024-07
PMC
Artificial intelligence in oncology: current applications and future perspectives - PMC
This article from January 2022 lists the Aquilion ONE (TSX-305A/6) V8.9 with AiCE as an FDA-approved device from June 2019, capable of acquiring and displaying cross-sectional volumes of the whole body, including the head, with the ability to image whole organs in a single rotation, within the context of AI in oncology.
2022-01
MDPI
Application of Artificial Intelligence Technology in Oncology: Towards the Establishment of Precision Medicine - MDPI
Published in November 2020, this article highlights the Aquilion ONE (TSX-305A/6) V8.9 with AiCE as an FDA-cleared device from June 2019, emphasizing its capability to acquire and display cross-sectional volumes of the whole body, including whole organs, using AiCE's deep learning reconstruction for improved image quality and noise reduction.
2020-11
FDA
K183046 - 510(k) Premarket Notification - FDA
This FDA 510(k) Premarket Notification document from June 2019 officially lists the Aquilion ONE (TSX-305A/6) V8.9 with AiCE from Canon Medical Systems Corporation, detailing its regulatory classification as a Class II computed tomography x-ray system.
2019-06
ResearchGate
(PDF) Artificial intelligence in oncology: current applications and future perspectives
This PDF document, last updated in November 2021, includes the Aquilion ONE (TSX-305A/6) V8.9 with AiCE as an FDA-approved device from June 2019, highlighting its capability to acquire and display cross-sectional volumes of the whole body, including the head, with the ability to image whole organs in a single rotation.
2021-11

Videos

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Frequently Asked Questions

AiCE utilizes a deep convolutional neural network to distinguish true signal from noise, significantly reducing image noise while enhancing spatial resolution and low-contrast detectability. This results in clearer, sharper images, potentially improving diagnostic confidence and enabling the visualization of subtle anatomical structures at equivalent or lower radiation doses.
AiCE has received FDA 510(k) clearance for its deep learning reconstruction technology, indicating its safety and effectiveness for clinical use. Canon Medical states it manages personal data with appropriate security measures and organizational structures to prevent loss, misuse, or unauthorized access, adhering to applicable privacy laws.
Yes, AiCE is designed to enable significant radiation dose reduction, with studies suggesting up to 81% less dose while maintaining equivalent or improved image quality compared to traditional methods. Unlike some iterative reconstruction techniques that can produce an unnatural or 'waxy' image texture, AiCE aims for a noise texture more similar to filtered back projection.
While generally superior in noise reduction and contrast enhancement, one study noted that a hybrid iterative reconstruction algorithm yielded a lower artifact index than AiCE in certain brain regions, despite AiCE showing lower noise. The ongoing research into deep learning reconstruction algorithms continues to explore their specific characteristics and optimal applications.
AiCE is Canon Medical's proprietary deep learning reconstruction, trained on extensive high-quality image data to optimize noise reduction and signal enhancement. Other vendors, such as GE Healthcare with its TrueFidelity algorithm, also offer deep learning reconstruction, each potentially having distinct characteristics in noise control and image texture.
AiCE is designed for seamless integration into routine CT workflow, operating quickly without requiring additional steps from the clinician. It is built directly into scan protocols, contributing to operational efficiency and consistent image quality across various examinations.
While specific pricing for the Aquilion ONE V8.9 with AiCE is not publicly available, it represents a significant capital investment in advanced imaging technology. Potential long-term cost savings could arise from reduced radiation dose protocols, which may extend X-ray tube life, and improved diagnostic confidence leading to more efficient patient management and fewer repeat scans.

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