Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE

by Canon Medical Systems Corporation  · Based in Japan → — Ultra-High Resolution CT Precision in Every Detail.
Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

The Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE is the world’s first Ultra-High Resolution CT (UHR CT) system, developed by Canon Medical Systems Corporation. It is designed to provide twice the resolution of conventional CT systems, enabling the visualization of anatomy as small as 150 microns. This advanced imaging capability is achieved through a newly designed UHR detector system with 160 rows and 0.25 mm thick detector elements, an industry-smallest focal spot X-ray tube, and miniaturized Digital Acquisition System (DAS) components.

A key innovation in the Aquilion Precision is the Advanced intelligent Clear-IQ Engine (AiCE), a Deep Learning Reconstruction (DLR) technology. AiCE leverages Deep Convolutional Neural Networks (DCNN) trained on advanced Model-Based Iterative Reconstruction (MBIR) algorithms. This allows for the reconstruction of sharp, clear, and distinct images with low noise and natural texture, at standard CT dose levels, and several times faster than traditional MBIR. The system supports 0.25 mm, 1024 matrix UHR CT images and can achieve 0.15 mm resolution.

Additional features include SURESubtraction for Ultra-High Resolution Subtraction CT, which removes bone, calcium, and stents from data sets for unobstructed views of arteries and enables iodine maps for perfusion assessment. The UHR couch is designed for patient and technologist comfort and safety, featuring a 47 cm width and 17 cm lateral table movement.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Ultra-High Resolution (UHR) CT
  • Advanced intelligent Clear-IQ Engine (AiCE) Deep Learning Reconstruction
  • Resolution down to 0.15 mm / 150 microns
  • 1024 x 1024 reconstruction matrix
  • SURESubtraction for Ultra-High Resolution Subtraction CT
  • UHR detector with 160 rows and 0.25 mm elements
  • UHR X-ray tube with industry's smallest focal spot
  • Adaptive Iterative Dose Reduction (AIDR 3D Enhanced)
  • 47 cm wide UHR couch with 17 cm lateral movement
  • Fast image reconstruction (up to 80 images per second)

Use Cases

  • Early detection of diseases
  • Detailed evaluation of the vascular system (e.g., aneurysms, collateral vessels)
  • Tumor staging and classification
  • Pre-surgical planning and post-surgical monitoring
  • Assessment of liver and lung diseases
  • High-resolution imaging for brain, cardiac, and musculoskeletal scans

What Physicians Need to Know

DICOM Support & Standards
Supports DICOM Service Classes, Information Objects, and Communication protocols, with conformance statements available. Complies with IEC60601-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-1-9, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA XR-25, NEMA XR-26, and NEMA XR-29 standards.
PACS Integration Method
Fully integrated with the CT system, eliminating the need for remote supercomputers or cloud access for reconstruction. Facilitates streamlined PACS workflow by reducing the number of image series radiologists need to manage.
Reading Room Workflow Impact
Seamlessly integrates into routine practice. Improves workflow by allowing noise-free 1mm axial images with instant access to reformatted sagittal and coronal views, reducing the need for multiple reconstructions and saving PACS storage. Offers fast reconstruction times, overcoming workflow limitations of other advanced iterative methods.
AI Model Architecture (deep learning approach)
Utilizes Advanced Intelligent Clear-IQ Engine (AiCE), a Deep Learning Reconstruction (DLR) technology powered by a Deep Convolutional Neural Network (DCNN). The DCNN is trained on high-quality images reconstructed with Model-Based Iterative Reconstruction (MBIR) to differentiate and suppress noise while enhancing signal.
Processing Speed (per study)
Reconstructs Ultra-High Resolution CT images several times faster than traditional clinical MBIR. Capable of reconstructing up to 80 images per second, and suppresses noise and enhances signal three to five times faster than traditional MBIR methods.
FDA Clearance Pathway (510k/De Novo)
Received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on October 21, 2019, for the Aquilion Precision with AiCE.
Supported Modalities
Primarily supports Computed Tomography (CT) as an Ultra-High Resolution CT system.
Sensitivity & Specificity Data
Achieves dose neutrality and equivalent low contrast detectability compared to conventional resolution CT with traditional hybrid iterative reconstruction techniques, while providing Ultra-High Resolution images. Demonstrates improved high contrast spatial resolution (e.g., 10lp/cm more for body) and low contrast detectability. Clinical evaluations show increased SNR (~25%) and CNR (~25%), with dose reductions of ~20% for body and ~40% for cardiac imaging. Capable of resolving anatomy as small as 150 microns.
RSNA/ACR Validation
Canon Medical Systems frequently presents and validates its technologies, including AiCE, at major conferences like RSNA. Clinical evaluations by American Board Certified Radiologists have confirmed the diagnostic quality of images reconstructed with AiCE.
Physician Tip

Leverage AiCE for routine and advanced CT studies to achieve Ultra-High Resolution imaging at standard doses, potentially improving diagnostic confidence for small lesions and fine anatomical structures. The enhanced image quality with reduced noise and improved contrast can be particularly beneficial in cardiac, lung, and musculoskeletal imaging. The streamlined workflow with integrated DLR can reduce reading time and PACS burden.

AiCE is deeply integrated within the Aquilion Precision CT system, functioning as an on-board reconstruction engine. Its design ensures seamless compatibility with existing DICOM-compliant PACS, optimizing data transfer and storage efficiency without requiring external computational resources or cloud connectivity for image reconstruction.

Details

Category Radiology & Imaging AI
Pricing Contact for pricing
DeploymentOn-premise (CT scanner hardware)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE received 510(k) clearance (K182901) from the U.S. Food and Drug Administration (FDA) on July 5, 2019, as a Computed Tomography X-Ray System. AiCE is cleared as a reconstruction algorithm that utilizes Deep Convolutional Neural Network methods to reduce image noise and improve image quality.

Integrations
EHR Not specified
Specialties Radiology

What the Web Says

The Canon Medical Systems Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE is an ultra-high resolution CT scanner that leverages Deep Learning Reconstruction (DLR) technology to enhance image quality and reduce noise. It is designed for whole-body imaging, including specialized studies of the head, abdomen, pelvis, chest, cardiac, and extremities. The system aims to provide diagnostic-quality images at radiation doses equivalent to standard CT.

Overall: Mixed

Strengths

  • Ultra-high resolution imaging, capable of resolving anatomy as small as 150 microns.
  • Advanced Intelligent Clear-IQ Engine (AiCE) significantly reduces image noise and improves image quality using deep convolutional neural networks.
  • Allows for super-high resolution studies at radiation doses equivalent to standard CT.
  • Improved high contrast spatial resolution.
  • Fast reconstruction times.
  • Capable of specialized studies, including cardiac, vascular, and inner ear applications.

Limitations

  • Some users have reported a user interface (GUI) that is not intuitive and can be difficult to navigate, requiring multiple steps for basic image editing and MPRs.
  • Concerns about image quality for certain body parts (spine/chest/pelvis) on older Aquilion Prime models, even with exposure factor adjustments.
  • The specific model (TSX-304A/1 and /2) V8.8 is an older version, with newer versions (V10.10 and V10.14) having expanded AiCE applications and gantry tilt operability.
  • Potential for a steep learning curve for new operators due to the complex interface.

Based on reviews from: Canon Medical Systems Corporation, DAIC, Medical Device Network, Tengrant Instruments, Innolitics, AuntMinnie, Reddit, Aura Medical, Atlantis Worldwide, LBN Medical - YouTube, Canon Medical Systems UK

Last updated: 2026-07-18

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Press & Coverage

U.S. Food and Drug Administration (FDA)
Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE 510(k) Premarket Notification
This regulatory announcement from the FDA details the 510(k) premarket clearance for the Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE, an ultra-high resolution whole body multi-slice helical CT scanner. It highlights the addition of AiCE (Advanced intelligent Clear-IQ Engine), a deep convolutional neural network reconstruction algorithm designed to reduce image noise and improve quality.
2019-07
Innolitics
System, X-Ray, Tomography, Computed u2014 FDA Product Code | Innolitics
This entry lists the Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE under the FDA product code JAK for Computed Tomography X-Ray Systems, indicating its clearance date and traditional pathway. It also provides a general description of computed tomography x-ray systems.
2019-07
BMJ Health & Care Informatics
How machine learning is embedded to support clinician decision making: an analysis of FDA-approved medical devices
This peer-reviewed article analyzes FDA-approved medical devices utilizing machine learning, including the Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE. It examines how these devices support clinician decision-making, the tasks they assist with, and the information they provide.
2021-04
Scribd
Artificial Intelligence and Machine Learning (AIML) - Enabled Medical Devices FDA
This document lists FDA-cleared Artificial Intelligence and Machine Learning (AIML)-enabled medical devices, featuring the Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE. It serves as a compilation of devices that incorporate AI/ML technologies.
unknown
Aidoc
CT/CTA radiology AI tools | FDA-cleared directory
This directory of FDA-cleared AI tools for CT/CTA radiology includes the Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE, noting its function in image analysis/processing. It categorizes the device by modality and anatomical application.
unknown

Videos

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Frequently Asked Questions

AiCE utilizes deep learning to reconstruct images, aiming to deliver exceptional spatial resolution and low-contrast detectability while significantly reducing noise. This can lead to clearer images, potentially improving diagnostic confidence and allowing for lower radiation doses without compromising image quality.
AiCE has received regulatory clearances, including FDA 510(k) and CE Mark, for its use in clinical imaging. Regarding data privacy, the AI processing typically occurs on anonymized image data locally on the scanner, ensuring patient identifiable information remains protected and compliant with relevant privacy regulations.
While highly effective, AiCE's performance may vary in extremely challenging cases or with highly unusual artifacts, similar to any reconstruction algorithm. Its efficacy in very specific, rare pathologies or highly motion-compromised studies might require careful clinical judgment, though it generally excels across diverse patient populations.
The Aquilion Precision with AiCE is distinguished by its unique deep learning reconstruction approach, which focuses on both noise reduction and preservation of fine details. This often results in a favorable balance of image quality and dose reduction, while its integration is designed to be seamless within existing CT workflows, enhancing efficiency.
AiCE is typically integrated as a core feature of the Aquilion Precision V8.8 system, often included in the initial capital equipment purchase. However, specific pricing structures, including potential software update agreements or service contracts, should be discussed directly with the vendor as they can vary.
Comprehensive training programs are typically offered by the vendor for both technologists and radiologists, covering system operation, AiCE specific protocols, and image interpretation. Ongoing technical support and access to clinical application specialists are also usually available to ensure optimal utilization and address any queries.

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