Aquilion Precision (TSX-304A/4) V10.10 with AiCE

by Canon Medical Systems Corporation  · Based in Japan → — AI-Powered Ultra-High Resolution CT: Precision in Every Detail at Low Dose
Cardiology Radiology

Contact vendor
Regulatory Status Disclosed

Overview

The Aquilion Precision (TSX-304A/4) V10.10 with AiCE from Canon Medical Systems Corporation is a groundbreaking Ultra-High Resolution (UHR) Computed Tomography (CT) system, designed to deliver exceptional image clarity and detail. It is the world’s first UHR CT system capable of resolving anatomy as small as 150 microns, providing image quality typically seen only in cath labs.

At its core is the Advanced intelligent Clear-IQ Engine (AiCE), an innovative Deep Learning Reconstruction (DLR) technology. AiCE leverages a Deep Convolutional Neural Network (DCNN) trained to differentiate signal from noise, effectively suppressing noise while enhancing the signal to produce sharp, clear, and distinct images at high speed. This AI-driven reconstruction allows clinicians to perform super-high resolution studies at radiation doses equivalent to standard resolution CT, significantly improving image quality without increasing patient exposure.

The system incorporates a 160-row, 0.25 mm detector, a 5.7-MHU large-capacity tube, and 0.35-second scanning, enabling wide-range scanning with short scan times. The Aquilion Precision also features SURESubtraction for CTA examinations, which removes bone, calcium, and stents from data sets for an unobstructed view of arteries, and can create iodine maps to assess contrast media distribution.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Ultra-High Resolution CT (UHR CT) capable of 150-micron resolution
  • Advanced intelligent Clear-IQ Engine (AiCE) Deep Learning Reconstruction (DLR)
  • Significant noise reduction and signal enhancement
  • Delivers sharp, clear, and distinct images
  • Enables high-resolution studies at standard CT radiation doses
  • Enhanced high contrast spatial resolution
  • Fast image reconstruction times
  • 160-row, 0.25 mm detector system
  • SURESubtraction for advanced CTA examinations and iodine mapping
  • Wide gantry opening (780mm) and high-capacity patient couch (up to 315 kg)

Use Cases

  • Whole body cross-sectional imaging (head, brain, lung, cardiac, musculoskeletal, abdomen, pelvis, extremities, inner ear)
  • Evaluation of the vascular system for disease and collateral vessel scoring
  • Tumor staging and classification
  • Pre-surgical planning and post-surgical monitoring
  • Cardiac CTA (Computed Tomography Angiography)
  • Visualization of local perfusion through iodine mapping

What Physicians Need to Know

DICOM Support & Standards
The Aquilion Precision (TSX-304A) V10.10 with AiCE supports DICOM standards, with conformance statements available to facilitate integration within DICOM-compliant hospital networks.
PACS Integration Method
Designed for seamless integration into routine clinical practice within a DICOM-compliant hospital network, implying standard DICOM-based image transfer and communication.
Reading Room Workflow Impact
AiCE provides an easy workflow, significantly reducing reconstruction times compared to traditional Model-Based Iterative Reconstruction (MBIR) algorithms, thereby improving efficiency without hindering clinical practice.
AI Model Architecture (deep learning approach)
AiCE (Advanced intelligent Clear-IQ Engine) is a Deep Learning Reconstruction (DLR) algorithm utilizing a Deep Convolutional Neural Network (DCNN). It is trained on vast amounts of high-quality image data, specifically from advanced MBIR, to differentiate and suppress noise while enhancing signal.
Processing Speed (per study)
AiCE reconstructs images several times faster than conventional clinical MBIR. The Aquilion Precision system can achieve an image reconstruction time of up to 80 images per second.
FDA Clearance Pathway (510k/De Novo)
The Advanced Intelligent Clear-IQ Engine (AiCE) for the Aquilion Precision received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on October 21, 2019. The Aquilion Precision system itself received initial 510(k) clearance in April 2018.
Supported Modalities (CT/MRI/X-ray/US)
The Aquilion Precision (TSX-304A/4) V10.10 with AiCE is an Ultra-High Resolution Computed Tomography (CT) system. It supports whole-body multi-slice helical CT scanning for various anatomical regions including brain, lung, cardiac, musculoskeletal, abdomen, pelvis, extremities, head, and inner ear applications.
Sensitivity & Specificity Data
AiCE enables Ultra-High Resolution CT at standard doses, providing twice the resolution of conventional CT and resolving anatomy as small as 150 microns. It significantly reduces noise, improves low contrast detectability (equivalent to conventional resolution images with AIDR 3D), and enhances high contrast spatial resolution. Studies show AiCE provides consistently higher detection performance (e.g., 48% higher for a 6mm lumen diameter compared to AIDR-FC18) and improved discrimination performance for stenotic lesions. Clinical evaluations have shown improved image quality with ~25% increase in SNR and CNR, and dose reduction up to 81% (on other AiCE-enabled CT systems).
RSNA/ACR Validation
While Canon Medical frequently presents and announces advancements at RSNA, the provided information does not explicitly detail formal validation by RSNA or ACR. However, the technology's performance has been supported by clinical evaluations and phantom studies, with results often shared at major radiology conferences like RSNA.
Physician Tip

Leverage AiCE for Ultra-High Resolution CT studies to achieve exceptional image clarity and detail at standard radiation doses, particularly beneficial for visualizing fine anatomical structures and subtle pathologies in areas like the brain, cardiac, lung, and musculoskeletal system. The improved low contrast detectability and noise reduction can enhance diagnostic confidence. Consider the workflow efficiencies gained from faster reconstruction times, allowing for higher patient throughput without compromising image quality. The ability to perform super-high resolution studies at doses equivalent to standard resolution CT is a key advantage for patient safety and diagnostic precision.

The Aquilion Precision with AiCE is designed for seamless integration into existing hospital imaging ecosystems through its comprehensive DICOM support. Ensure that your PACS and viewing workstations are compatible with the latest DICOM conformance statements for optimal image transfer, storage, and display of the high-resolution datasets generated by AiCE. While specific PACS integration methods beyond DICOM are not detailed, the system's focus on a 'DICOM compliant hospital network' suggests standard interoperability. For advanced workflow automation features like INSTINX, verify compatibility and integration pathways with your current IT infrastructure.

Details

Category Radiology & Imaging AI
Pricing Contact vendor — Not publicly disclosed
DeploymentOn-premise (medical device)
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

The Aquilion Precision (TSX-304A/4) V10.10 with AiCE received 510(k) FDA clearance (K220986) on September 12, 2022. This whole-body multi-slice helical CT scanner utilizes AiCE, a Deep Convolutional Neural Network-based noise reduction algorithm, to improve image quality and reduce noise across various anatomical applications, including abdomen, pelvis, lung, and cardiac imaging.

Integrations
EHR Not specified
Specialties Cardiology, Radiology

What the Web Says

The Canon Medical Aquilion Precision (TSX-304A/4) V10.10 with AiCE is an ultra-high resolution CT scanner designed to provide detailed imaging with advanced AI-powered reconstruction. It aims to deliver image quality typically seen in cath labs at standard CT doses, enhancing diagnostic confidence across various medical applications. The system leverages deep learning to differentiate signal from noise, resulting in sharper and clearer images.

Overall: Positive

Strengths

  • Ultra-high resolution imaging, resolving anatomy as small as 150 microns.
  • Advanced intelligent Clear-IQ Engine (AiCE) uses deep learning to reconstruct sharp, clear, and distinct images with low noise and natural texture.
  • Ability to perform super-high resolution studies at doses equivalent to standard resolution CT.
  • SURESubtraction technology removes bone, calcium, and stents from data sets for unobstructed views of arteries and allows for iodine mapping to assess contrast media distribution.
  • Fast reconstruction times, several times faster than traditional Model-Based Iterative Reconstruction (MBIR).
  • New UHR detector system, X-ray tube, gantry, and couch technology contribute to enhanced image quality and precision.

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra.
  • Information on pricing and long-term maintenance costs is not available in the provided snippets.
  • Limited information on user-reported workflow integration challenges or learning curve for new users.

Based on reviews from: Canon Medical Systems Corporation, Applied Radiology, AuntMinnie, Innolitics, Tengrant Instruments, Guided Solutions, Atlantis Worldwide, DOTmed

Last updated: 2026-07-18

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Press & Coverage

FDA
Aquilion Precision (TSX-304A/4) V10.10 with AiCE 510(k) Premarket Notification
This regulatory announcement details the FDA's clearance of the Aquilion Precision (TSX-304A/4) V10.10 with AiCE, expanding its use to lung/cardiac applications and gantry tilt operability. The device is an ultra-high resolution whole-body multi-slice helical CT scanner that utilizes Deep Convolutional Neural Network methods for noise reduction and improved image quality.
2022-09
Canon Medical Systems USA
Aquilion Precision (TSX-304A/4) V10.10 with AiCE
This entry confirms the FDA clearance of Aquilion Precision (TSX-304A/4) V10.10 with AiCE as a radiology AI listing for CT/CTA. It provides an overview of the system's capabilities and regulatory status.
unknown
Innolitics
FDA Product Code JAK - System, X-Ray, Tomography, Computed
Innolitics lists the Aquilion Precision (TSX-304A/4) V10.10 with AiCE under FDA product code JAK, indicating its clearance as a Computed Tomography X-Ray System on September 12, 2022. This resource provides a comprehensive list of cleared medical devices.
2022-09
Innolitics
Aquilion Precision (TSX-304A/4) V10.14 with AiCE (K223726) u2014 FDA 510(k)
This FDA 510(k) summary for a later version, V10.14, references the Aquilion Precision (TSX-304A/4) V10.10 with AiCE as its predicate device. It highlights the expansion of AiCE use to extremities, head, and inner ear applications in the newer version.
2022-11
FDA-cleared directory
CT/CTA radiology AI tools | FDA-cleared directory
This directory lists Aquilion Precision (TSX-304A/4) V10.10 with AiCE as an FDA-cleared radiology AI tool for CT/CTA. It categorizes the device under image analysis/processing.
unknown
BEUDAMED
CANON INC. - BEUDAMED
BEUDAMED includes Aquilion Precision (TSX-304A/4) V10.10 with AiCE in its listing of Canon Medical Systems Corporation products. This indicates its presence in broader medical device databases.
unknown

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Frequently Asked Questions

AiCE (Advanced intelligent Clear-IQ Engine) leverages deep learning to differentiate signal from noise, significantly improving image quality by reducing noise, enhancing spatial resolution, and boosting low-contrast detectability. This allows for the acquisition of ultra-high resolution CT images at standard radiation doses, potentially leading to more precise diagnoses.
AiCE has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with the Aquilion Precision ultra-high resolution CT scanner and other Canon Medical CT systems. As an image reconstruction algorithm, AiCE primarily processes raw image data to improve quality, and its operation typically does not involve direct handling of patient-identifiable information beyond what is inherent in the imaging study itself.
AiCE is a Deep Learning Reconstruction (DLR) algorithm that is trained on high-quality Model-Based Iterative Reconstruction (MBIR) images, offering superior noise reduction, improved spatial resolution, and faster reconstruction speeds compared to traditional iterative reconstruction methods like AIDR 3D and even MBIR. This allows for ultra-high resolution imaging with natural image texture and excellent low-contrast detectability, overcoming some of the challenges associated with previous iterative techniques.
Specific pricing and licensing models for AiCE are proprietary to Canon Medical Systems and are generally not publicly disclosed. Typically, the AiCE technology is integrated as a core feature or an optional enhancement within the overall purchase or lease agreement of the Aquilion Precision CT system.
While generally superior, some studies have noted that in specific instances, such as with the application of SEMAR AiCE for brain CTA, image quality might decrease, necessitating case-by-case assessment. Additionally, AiCE images have shown a higher median artifact index in the posterior cranial fossa compared to AIDR-3D in unenhanced brain CT, and while DLR significantly reduces noise, it can still increase at very low X-ray levels.
AiCE is designed for seamless integration into existing CT workflows, with its deep learning reconstruction occurring rapidly, often several times faster than traditional MBIR. This fast reconstruction speed allows clinicians to leverage the benefits of deep learning for high-quality, low-noise, ultra-high resolution images without hindering throughput in busy clinical environments.

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