Aquilion Serve (TSX-307A/1)

Cardiology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

The Aquilion Serve (TSX-307A/1) is a whole-body multi-slice helical CT scanner from Canon Medical Systems Corporation, designed to enhance efficiency, consistency, and patient care in radiology departments. It integrates advanced AI-enabled technologies and automated workflows to simplify operations, reduce scan times, and deliver high-quality, low-dose imaging. The system features the innovative INSTINX workflow solution, which redesigns the entire CT scanning experience for intuitive and easy learning, leading to up to a 40% reduction in workflow steps. Key to its imaging capabilities is the Advanced intelligent Clear-IQ Engine (AiCE) Deep Learning Reconstruction (DLR), which produces sharp, clear, and distinct images with reduced noise across various anatomical areas. Hardware innovations, such as an 80 cm wide-bore gantry, built-in positioning cameras, and Tech Assist Lateral Slide, prioritize patient comfort and safety while streamlining setup. The Aquilion Serve is engineered for dependable results, consistent clinical outcomes, and a compact, eco-friendly design that fits most existing CT rooms, minimizing infrastructure requirements and energy costs.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • INSTINX AI-assisted workflow automation for up to 40% reduced workflow steps
  • Advanced intelligent Clear-IQ Engine (AiCE) Deep Learning Reconstruction (DLR) for sharp, clear images at low dose
  • 3D Landmark Scan and Anatomical Landmark Detection (ALD) for automatic scan planning
  • SilverBeam filter for ultra-low dose scanning
  • 80 cm wide-bore gantry for enhanced patient access and comfort
  • Tech Assist Lateral Slide for efficient patient setup
  • PUREVision detector with 80 rows and 0.5 mm resolution
  • Fast rotation speed (0.5 sec / 0.35 sec*)
  • SURECardio engine for robust cardiac CT examinations
  • Dynamic scan mode, Exposure reduction mode, Dual Energy scanning, and Extended field of view (V1.3 features)

Use Cases

  • Whole body CT imaging, including head, abdomen, and pelvis
  • Lung and cardiac imaging
  • Extremities and inner ear applications
  • Routine and complex diagnostic imaging
  • Pediatric and bariatric patient exams
  • Lung Cancer Screening

What Physicians Need to Know

FDA Clearance Pathway
510(k) cleared. The Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i received premarket clearance under K222819 on March 3, 2023. A subsequent version, V1.3, received 510(k) clearance under K231281 on September 19, 2023.
Supported Modalities
Computed Tomography (CT). It is a whole-body multi-slice helical CT scanner indicated for acquiring and displaying cross-sectional volumes of the whole body, including the head, abdomen, pelvis, lung, cardiac, extremities, and inner ear applications.
AI Model Architecture
Advanced intelligent Clear-IQ Engine (AiCE) utilizes Deep Convolutional Neural Network methods for noise reduction and improved image quality. It distinguishes signal from noise to deliver sharp, clear, and distinct CT images.
Reading Room Workflow Impact
Features the INSTINX AI-assisted workflow solution, designed for operational efficiencies. This includes automated protocol setup, automated scanner workflow, remote scan support, zero-click post-processing, and AI-assisted patient triage. It incorporates a 3D Landmark Scan with Anatomical Landmark Detection (ALD) for automatic scan planning, which can reduce workflow steps by up to 40% and scan planning time by 24%. Automated hanging layouts are also supported for fast image review.
Processing Speed (per study)
Offers a reconstruction speed of up to 70 frames per second (fps) for helical scans.
DICOM Support & Standards
Canon Medical Systems products, including the Aquilion Serve TSX-307A, support DICOM and conform to IHE Technical Frameworks. Specific IHE Integration Statements are available for iSeries V1.2 or later and iSeries V1.3 or later.
PACS Integration Method
Integration is facilitated through adherence to DICOM standards and IHE Integration Profiles, ensuring interoperability with other systems supporting the same profiles.
Sensitivity & Specificity Data
While specific disease detection sensitivity and specificity data are not explicitly provided, image quality metric evaluations demonstrate equivalent or improved performance compared to predicate devices and traditional reconstruction methods (FBP, AIDR 3D) across various parameters. These include noise texture, spatial resolution, Contrast-to-Noise Ratios (CNR), CT Number Accuracy, Uniformity, Slice Sensitivity Profile (SSP), Modulation Transfer Function (MTF), Standard Deviation of Noise (SD), and Low Contrast Detectability (LCD). Anatomical Landmark Detection (ALD) for scan range planning shows 97% accuracy.
RSNA/ACR Validation
Canon Medical Systems showcases its CT innovations, including the Aquilion Serve SP, at events like RSNA 2025, highlighting advancements in image quality, workflow integration, and AI-driven reconstruction technologies.
Physician Tip

Leverage the AiCE Deep Learning Reconstruction for consistently sharp, clear, and low-noise images, which can enhance diagnostic confidence, especially in challenging anatomical areas. Utilize the INSTINX workflow with its AI-assisted automation, including 3D Landmark Scan and Anatomical Landmark Detection, to streamline scan planning, reduce variability between operators, and improve overall department efficiency. The system's ability to provide high-quality, low-dose imaging across various body regions makes it suitable for a broad range of routine and complex CT examinations.

The Aquilion Serve (TSX-307A/1) supports DICOM standards and IHE Integration Profiles (specifically for iSeries V1.2 and V1.3 or later), which are crucial for seamless integration into existing PACS and hospital IT infrastructure. This adherence to industry standards ensures robust interoperability for image transfer and workflow communication within a radiology department.

Details

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

The Aquilion Serve (TSX-307A/1) V1.3 received FDA clearance (K231281) on September 19, 2023. It is a whole body multi-slice helical CT scanner indicated to acquire and display cross-sectional volumes of the whole body, including the head. It utilizes AiCE (Advanced Intelligent Clear-IQ Engine) for noise reduction and improved image quality in applications such as abdomen, pelvis, lung, cardiac, extremities, head, and inner ear.

Integrations
EHR Not specified
Specialties Cardiology, Radiology

What the Web Says

The Canon Aquilion Serve (TSX-307A/1) is generally well-regarded for its advanced imaging capabilities, particularly in cardiac and neurological applications, and its focus on patient safety through low-dose protocols. Reviewers often highlight its AI-powered features for image reconstruction and workflow optimization, though some note a learning curve for new users.

Overall: Positive

Strengths

  • Excellent image quality, especially for complex cases like cardiac CT
  • Low-dose imaging capabilities enhance patient safety
  • AI-driven features improve workflow and image reconstruction
  • User-friendly interface once familiarized
  • Reliable performance and uptime reported by many users
  • Good support and service from Canon

Limitations

  • Can have a significant learning curve for new operators
  • Initial cost can be high for smaller facilities
  • Software updates can sometimes be disruptive
  • Some users report the system can be slow to boot up
  • Integration with existing PACS systems can sometimes be challenging
  • Physical footprint might be large for some imaging suites

Based on reviews from: AuntMinnie.com, Radiology Today, MD Buyline, ECRI Institute, Various physician forums and review sites

Last updated: 2026-07-17

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Press & Coverage

RadAI Slice
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i | FDA Radiology AI Device
The Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i is a whole-body multi-slice helical CT scanner that uses an AI-based noise reduction algorithm to improve image quality and reduce noise for various scans. It received FDA approval on March 3, 2023, after a submission on September 19, 2022.
2023-03
FDA
March 3, 2023 Canon Medical Systems Corporation Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA
This FDA document details the substantial equivalence determination for the Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i to a predicate device, outlining its technology, intended use, and performance. The device is a whole-body multi-slice helical CT scanner designed for specialized studies.
2023-03
Scribd (FDA document)
FDA Clearance for Aquilion Serve V1.3 | PDF | Food And Drug Administration - Scribd
The Aquilion Serve (TSX-307A/1) V1.3 received FDA clearance, being deemed substantially equivalent to its predecessor, V1.2 with AiCE-i. This Class II computed tomography x-ray system includes advanced features like Dynamic scan mode and exposure reduction capabilities, with cybersecurity considerations addressed in its premarket submission.
2023-09
RadAI Slice
Aquilion Serve (TSX-307A/1) V1.3 | FDA Radiology AI Device
Canon Medical Systems Corporation's Aquilion Serve (TSX-307A/1) V1.3, a whole-body CT scanner, received 510(k) clearance on September 19, 2023. This device is highlighted in a radiology AI news feed that covers research and regulatory approvals in the field.
2023-09
Innolitics (FDA 510(k) database)
Aquilion Serve (TSX-307A/1) V1.3 (K231281) — FDA 510(k) | Innolitics
This FDA 510(k) summary confirms the substantial equivalence of the Aquilion Serve (TSX-307A/1) V1.3, cleared on September 19, 2023. It outlines the device's classification as a Class II Computed Tomography X-ray System and its compliance with regulatory requirements.
2023-09
GlobalData
Computed Tomography (CT) Systems Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies - GlobalData
A GlobalData report on Computed Tomography (CT) Systems Pipeline mentions the Aquilion Serve (TSX-307A/1) in the context of recent developments in the CT industry. The report provides an overview of pipeline products and key companies in the CT systems market.
2024-05
FDA.report
September 19, 2023 Canon Medical Systems Corporation Orlando Tadeo Sr. Manager, Regulatory Affairs Canon Medical Systems USA - FDA.report
This FDA document confirms the substantial equivalence of the Aquilion Serve (TSX-307A/1) V1.3 to its predecessor, V1.2 with AiCE-i. The V1.3 model incorporates new features such as Dynamic scan mode, Exposure reduction mode, Dual Energy scanning, and an Extended field of view.
2023-09
FDA
K222819 - 510(k) Premarket Notification - FDA
This FDA 510(k) Premarket Notification provides details for the Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i, submitted by Canon Medical Systems Corporation. It includes information on the applicant, correspondent, regulation number, and product code.
2026-06

Videos

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Frequently Asked Questions

The Aquilion Serve utilizes AiCE (Advanced intelligent Clear-IQ Engine), a Deep Learning Reconstruction technology, to significantly reduce image noise and improve low-contrast detectability, leading to sharper, clearer images. This AI also enables substantial radiation dose reduction, up to 80-90% compared to traditional methods, thereby enhancing patient safety without compromising diagnostic confidence.
INSTINX, the Aquilion Serve's AI-assisted workflow, automates tasks like patient positioning and scan planning with 97% accuracy, reducing workflow steps by up to 40%. This automation streamlines operations, increases patient throughput, and ensures consistent results across operators, freeing up staff to focus more on patient care.
The Aquilion Serve (TSX-307A/1) is FDA-cleared as a Class II computed tomography x-ray system, complying with radiation safety standards (21 CFR §1010 and §1020) and manufactured under ISO 13485. It also adheres to FDA guidance for cybersecurity in medical devices, ensuring the integrity and security of its AI functionalities.
While designed for broad application, optimal performance of AI features like AiCE can be influenced by specific clinical settings and patient preparation. Additionally, the optimization of injected contrast dose is recommended only within approved drug labeling ranges.
The Aquilion Serve features Canon's proprietary AiCE Deep Learning Reconstruction, which is highlighted for its ability to deliver exceptional image quality at significantly reduced doses across all body regions. While other manufacturers offer AI, AiCE is presented as a paradigm shift in CT reconstruction, rivaling advanced model-based iterative reconstructions.
The integrated AI enhances value by improving diagnostic confidence through superior image quality at lower doses, and by driving operational efficiencies through automated workflows. This leads to faster patient throughput, reduced training requirements, and consistent outcomes, ultimately contributing to a more productive and cost-effective imaging department.
As an FDA-cleared medical device, the Aquilion Serve adheres to stringent regulatory requirements for data handling, including compliance with 21 CFR Part 807 for registration and listing, and 21 CFR Part 803 for medical device reporting. Canon Medical Systems also emphasizes adherence to ISO 13485 and cybersecurity guidelines, which encompass patient data security.

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