Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I

by Canon Medical Systems Corporation  · Based in Japan → — Expand your view with AI-powered imaging for confident CT Guided Interventions and CT Simulation.
Interventional Radiology Oncology Radiology

N/a
Regulatory Status Disclosed

Overview

The Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I from Canon Medical Systems Corporation is a whole-body multi-slice helical CT scanner designed to transform radiation oncology and advanced diagnostic imaging. It combines the industry’s largest 90 cm wide bore and an extended 90 cm Field-of-View (eFOV) reconstruction, enhancing patient access, comfort, and safety, particularly for bariatric patients and challenging positioning requirements.

At its core is the Advanced intelligent Clear-IQ Engine (AiCE), an innovative Deep Learning Reconstruction (DLR) technology. AiCE utilizes a Deep Convolutional Neural Network (DCNN) trained with high-quality data to differentiate signal from noise, effectively reducing noise while preserving true signal and enhancing anatomical detail. This results in sharp, clear, and distinct images with improved low-contrast detectability and spatial resolution, often at lower radiation doses compared to conventional methods. For the V10.6 version, AiCE-I is applicable for abdomen, pelvis, lung, extremities, head, and inner ear applications.

The system also features SUREWorkflow technologies to streamline operations, offering fast acquisition and reconstruction speeds up to 70 frames per second. Its 80-row detector provides 4 cm coverage per rotation, enabling faster scans and efficient respiratory motion management through 4D CT capabilities with phase and amplitude sorting. Additionally, the Aquilion Exceed LB integrates Single Energy Metal Artifact Reduction (SEMAR) to improve visualization around metallic implants.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Advanced intelligent Clear-IQ Engine (AiCE) Deep Learning Reconstruction (DLR)
  • World's largest 90 cm wide bore for enhanced patient access and comfort
  • Extended 90 cm Field-of-View (eFOV) reconstruction
  • 4 cm wide detector coverage (80-row detector) for fast scanning
  • SUREWorkflow Technologies for streamlined operations
  • Low-dose imaging capabilities
  • Single Energy Metal Artifact Reduction (SEMAR)
  • 4D CT capabilities for respiratory motion management
  • Support for bariatric patients
  • Fast reconstruction speeds up to 70 frames per second

Use Cases

  • Radiation Therapy Planning and CT Simulation
  • CT Guided Interventions
  • General Diagnostic Radiology
  • Oncology (tumor delineation and follow-up)
  • Neurological imaging
  • Trauma assessment

What Physicians Need to Know

Key Capabilities
Features AiCE-i (Advanced intelligent Clear-IQ Engine) Deep Learning Reconstruction (DLR) for superior image quality, noise reduction, and enhanced spatial resolution across various body regions. Offers a 90 cm wide bore for improved patient access, comfort, and positioning, particularly for bariatric patients and radiation therapy. Includes an optional 90 cm extended Field-of-View (eFOV) and a 0.5 mm PUREViSION detector with 80 rows, capable of 160 slices per rotation. Supports fast reconstruction speeds up to 70 fps and incorporates SUREWorkflow Technologies, Single Energy Metal Artifact Reduction (SEMAR), and Adaptive Iterative Dose Reduction (AIDR 3D Enhanced).
Clinical Utility
Primarily designed for fast, smart, and accurate CT simulation in radiation oncology, enhancing target identification and contouring of organs at risk. Provides high-quality, low-dose CT scans for clear visualization of lesions and supports optimizing treatment positions for high-accuracy therapy planning. Improves care for bariatric patients and facilitates CT-guided interventional procedures. Applicable in trauma, neurology, and general interventional radiology, enabling efficient workflows without compromising image quality or reproducibility.
Integration Options
Designed to connect seamlessly with existing radiation therapy planning devices, positioning lasers, and a range of respiratory gating devices. Supports connectivity with Canon's Vitreau2122 imaging solutions for enhanced clinical insights and facilitates automatic transfer of reconstructed images to simulation or planning systems.
Compliance Status
FDA 510(k) cleared (K203042) as a Class II medical device (Computed Tomography X-ray System, Product Code JAK) on December 10, 2020. Conforms to applicable Performance Standards for Ionizing Radiation Emitting Products (21 CFR, Subchapter J, Part 1020) and IEC standards for Medical Devices and CT Systems. Cybersecurity documentation was included in the FDA submission. Canon Medical Systems Corporation holds ISO 9001, ISO 13485, and ISO 14001 certifications.
Pricing Model
Contact Vendor for pricing details, as this information is not publicly disclosed.
User Experience
Features a wide, open, and low system design with a low table height (33 cm) to enhance patient access, comfort, and safety. Incorporates SUREWorkflow Technologies for an intelligent workflow and offers remote patient adjustment (SUREPosition) and couch movement (Tech-Assist Lateral Slide) for efficient and accurate positioning. Hybrid CT fluoroscopy with one-handed operation and a versatile touchscreen provides finer control during interventional procedures.
Support Quality
The system is designed for high reliability and is backed by Canon Medical's highly rated customer service.
Implementation Complexity
Designed for fast, cost-effective, and efficient installation with minimal disruption. Its compact gantry and small footprint allow it to fit into most standard radiation oncology suites without requiring major building renovations.
Evidence Base
Received FDA 510(k) clearance based on substantial equivalence to predicate devices (Aquilion Prime SP V10.2 with AiCE-i and Aquilion LB V6.0). The clearance was supported by software validation, risk management, design controls, and performance data. The core AiCE algorithm has not been modified or retrained since its previous clearance.
Physician Tip

Leverage the 90 cm wide bore for comfortable and precise patient positioning, especially for bariatric patients or complex setups in radiation therapy. Utilize AiCE-i Deep Learning Reconstruction for superior image quality, reduced noise, and enhanced anatomical delineation, crucial for accurate contouring in oncology. Take advantage of features like SUREPosition and Tech-Assist Lateral Slide for remote and accurate patient adjustments, streamlining workflow. Employ respiratory gating capabilities for managing motion artifacts in thoracic and abdominal scans, improving planning accuracy. Consider the extended Field-of-View (eFOV) option for comprehensive visualization, particularly for skin margins in radiation therapy planning.

The Aquilion Exceed LB is designed for seamless integration with existing radiation therapy planning devices, positioning lasers, and respiratory gating systems to optimize workflow. Connectivity with Canon's Vitreau2122 imaging solutions is also supported, facilitating access to clinical insights. Automatic transfer of reconstructed images to simulation or planning systems further enhances efficiency.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing N/a — Contact vendor for pricing information.
DeploymentOn-premise (medical hardware device)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-i received 510(k) FDA clearance (K203042) on December 10, 2020. It is indicated to acquire and display cross-sectional volumes of the whole body, including the head, and AiCE is a noise reduction algorithm improving image quality for various applications like abdomen, pelvis, lung, extremities, head, and inner ear.

Integrations
EHR Not specified
Specialties Interventional Radiology, Oncology, Radiology

What the Web Says

The Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I is a whole-body multi-slice helical CT scanner that received FDA clearance on December 10, 2020. It incorporates the Advanced intelligent Clear-IQ Engine (AiCE), a deep convolutional neural network-based noise reduction algorithm designed to improve image quality and reduce noise in various anatomical applications. The system is intended for use by trained and qualified physicians to acquire and display cross-sectional volumes of the entire body, including the head, and to perform specialized studies using its indicated software and hardware.

Overall: Positive

Strengths

  • Improved image quality through AiCE noise reduction algorithm
  • Reduced image noise
  • Capable of whole-body imaging, including the head
  • Can perform specialized studies with indicated software/hardware
  • Demonstrated dose reduction of up to 82% for AiCE Abdomen relative to FBP in a phantom study

Limitations

No significant limitations found in public reviews. Consider checking vendor documentation or requesting a demo for a thorough evaluation.

Based on reviews from: Innolitics, Radiology AI Tools Directory, accessdata.fda.gov, Scribd, Buyer shortlist, Canon Medical Systems - Physician Ai Tools

Last updated: 2026-07-17

Ratings & Reviews

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Press & Coverage

Innolitics
Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I Cleared Traditional
This entry indicates the FDA clearance of the Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I as a traditional computed tomography x-ray system on December 10, 2020.
2020-12
accessdata.fda.gov
U.S. Food & Drug Administration 510(k) Premarket Notification
This FDA document details the 510(k) premarket notification for the Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-i, outlining its device description, intended use, and substantial equivalence to predicate devices.
2020-12
Radiology AI Tools Directory
CT/CTA radiology AI tools | FDA-cleared directory
The Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I is listed in an FDA-cleared directory of CT/CTA radiology AI tools, indicating its capability for image analysis and processing.
unknown
Canon Medical Systems
Canon Medical Systems - Physician Ai Tools
Canon Medical Systems highlights the Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I as an oncology AI tool, suggesting its application in cancer diagnosis and treatment planning.
2026-04
FDA.report
CANON INC. FDA Filings
This FDA filing record confirms the clearance of the Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I on December 10, 2020, under product code JAK.
2020-12
Radiology AI Tools Directory
Search FDA-cleared listings - Radiology AI Tools Directory
The Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I is listed as an FDA-cleared device for image analysis/processing in CT/CTA modalities, with the decision date of December 10, 2020.
2020-12

Videos

Product demos, reviews, and walkthroughs for Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I.

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Frequently Asked Questions

AiCE-I is a Deep Learning Reconstruction (DLR) technology that uses artificial intelligence to differentiate signal from noise, significantly improving image resolution and low-contrast detectability. This results in sharper, clearer, and more distinct images, which can boost clinical confidence for accurate and precise planning in radiation oncology, even at low doses.
The Aquilion Exceed LB CT system with AiCE has received 510(k) clearance from the U.S. Food & Drug Administration (FDA). While specific data privacy compliance (e.g., HIPAA, GDPR) is generally managed at the institutional level, Canon Medical designs its systems to facilitate workflow while maintaining image quality and reproducibility, and DLR algorithms are trained to differentiate structure from noise using sample data sets.
AiCE-I is designed for whole-body imaging, including head, abdomen, pelvis, lung, and extremities, and is applicable across a broad range of anatomies and applications. While it significantly reduces noise and improves image quality, physicians should always apply clinical judgment, and specific limitations might be related to extreme motion artifacts or highly specialized, niche protocols not explicitly optimized for DLR. AiCE has been evaluated for HU stability suitable for radiotherapy planning.
AiCE-I is a deep convolutional neural network (DCNN) image reconstruction technology that learns from high-quality Model-Based Iterative Reconstruction (MBIR) images to suppress noise and enhance signal, often 3-5 times faster than traditional MBIR. It aims to overcome challenges in clinical adoption faced by traditional MBIR, such as image appearance or reconstruction speed, by providing sharp, clear images with improved low-contrast detectability and spatial resolution.
The AiCE-I technology is integrated into the Aquilion Exceed LB system, meaning its cost is typically part of the overall system acquisition. While specific pricing models can vary by vendor and region, the AI component is generally bundled, and ongoing licensing fees for the core DLR algorithm are usually included in service agreements or system updates. The value proposition includes potential for dose reduction and workflow efficiency.
AiCE-I is designed for seamless integration into routine CT workflows, aiming for operational efficiency without requiring extra steps from the user. Canon Medical typically provides application specialists for easy implementation and training, ensuring that staff can quickly adopt the new technology and leverage its benefits.
Clinical studies and evaluations have shown that AiCE-I can maintain Hounsfield Unit (HU) stability suitable for radiotherapy treatment planning and enable dose optimization without compromising image quality. It has been demonstrated to reduce noise and improve image quality, leading to a 12% reduction in mean DLP for breast radiotherapy patients in one study, with clinical images showing less noise and sharper detail.

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