Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

by Canon Medical Systems Corporation  · Based in Japan → — Ultra Helical CT that delivers all-around performance with AI-assisted imaging.
Cardiology Oncology Radiology
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Regulatory Status Disclosed

Overview

The Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i is a state-of-the-art computed tomography (CT) system from Canon Medical Systems Corporation, designed to provide comprehensive clinical capabilities and advanced imaging. At its core is the Advanced intelligent Clear-IQ Engine (AiCE-i), a deep convolutional neural network (DCNN) image reconstruction technology. AiCE-i is trained to differentiate signal from noise, suppressing noise while enhancing signal to deliver sharp, clear, and distinct images with improved spatial resolution and low-noise properties, often at reduced radiation doses.

The Aquilion Prime SP system itself is a 40-row CT, capable of generating 160 unique slices per rotation with 0.35-second scanning, and can be expanded to 80 active detector rows with an optional Dynamic Volume CT Upgrade Kit. It features a wide 78 cm gantry bore and a 660-pound patient-weight-capacity couch, making it suitable for a diverse patient population, from pediatric to bariatric. Key technologies like PUREViSION Optics contribute to reduced dose and improved low contrast detectability. The system is engineered to enhance workflow, improve diagnostic confidence, and provide patient-centric imaging solutions, including features for cardiac, oncology, and trauma imaging.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AiCE-i (Advanced intelligent Clear-IQ Engine - integrated) Deep Learning Reconstruction
  • 40-row CT System, expandable to 80 rows with optional Dynamic Volume CT Upgrade Kit
  • 160 slices per rotation with 0.35-second scanning
  • 78 cm gantry bore and 660-pound patient capacity couch
  • PUREViSION Optics for dose reduction and improved low contrast detectability
  • SURECardio Helical Prospective for cardiac imaging and arrhythmia compensation
  • SEMAR (Single Energy Metal Artifact Reduction) for improved visualization near metal implants
  • Variable Helical Pitch with three phases (vHP3) for optimized workflow and dose reduction
  • Dual Energy scanning for tissue characterization and lesion analysis
  • Power-assisted patient positioning for expedited setup and reduced technologist effort
  • Mobile or modular deployment options for flexible installation

Use Cases

  • General diagnostic radiology
  • Cardiac imaging and angiography
  • Oncology imaging (detection, staging, treatment planning)
  • Emergency and trauma scanning
  • Pediatric imaging
  • Bariatric patient studies

What Physicians Need to Know

ECG/EKG Analysis Capability
The system utilizes ECG gating for precise cardiac CT image acquisition. Its intelligent SURECardio engine adapts exposure in real-time to patient heart rate, including during arrhythmias, to ensure diagnostic image reconstruction.
Cardiac CT/MRI Analysis
Offers robust cardiac CT examinations with the intelligent SURECardio engine, which automates and adapts scan parameters in real-time. AiCE-i (Advanced intelligent Clear-IQ Engine - integrated) uses Deep Learning Reconstruction to deliver sharp, clear, and distinct cardiac images with reduced noise, enhancing diagnostic confidence for various cardiac applications.
Arrhythmia Detection Accuracy
The SURECardio engine detects arrhythmias or irregular heartbeats in real-time during the scan and automatically compensates by adapting the exposure window to ensure that image reconstruction provides a diagnostic examination.
Heart Failure Risk Prediction
Direct features for heart failure risk prediction from CT imaging are not explicitly detailed for this specific device in the provided information.
Coronary Artery Assessment
Enables robust Cardiac CTA with excellent visualization of the lumen, even in the presence of calcified plaque, due to AiCE-i's low-noise and high-resolution characteristics. SURESubtraction technology can remove bone, calcium, and stents from data sets, providing an unobstructed view of the arteries and allowing for iodine mapping to assess contrast distribution.
Cardiac Monitoring Integration
Integrates ECG for prospective and retrospective gating, allowing the SURECardio engine to adapt to the patient's heart rate automatically, even with unexpected arrhythmias, to ensure optimal image quality for cardiac scans.
AHA/ACC Guideline Alignment
As a high-performance CT system, it supports guideline-driven cardiac diagnostic pathways by providing high-quality, low-dose imaging for coronary artery disease assessment and other cardiac conditions.
Real-Time Alert Capability
The SURECardio engine provides real-time adaptive exposure adjustments during arrhythmia to maintain diagnostic image quality, acting as a real-time compensation mechanism during scanning.
Physician Tip

Leverage AiCE-i's Deep Learning Reconstruction for superior image quality, especially in challenging cardiac cases (e.g., pediatric, bariatric, or patients with arrhythmias), enabling more confident diagnoses with reduced noise and dose. Utilize the SURECardio engine for automated and adaptive cardiac CT examinations, ensuring consistent diagnostic quality even with irregular heartbeats. Employ SURESubtraction for clear visualization of coronary arteries by effectively removing bone and calcification, which is crucial for plaque assessment and stent evaluation. The system's dose reduction capabilities should be maximized to enhance patient safety without compromising diagnostic performance.

The Aquilion Prime SP with AiCE-i features protocol-integrated application solutions for seamless adoption of advanced CT procedures. It integrates with ECG for real-time cardiac gating and heart rate adaptation during scanning. The system provides volume sets that can be used for specialized studies with compatible software and hardware, facilitating comprehensive cardiac analysis.

Details

Category Cardiology AI, Oncology AI, Radiology & Imaging AI
Pricing Contact vendor for pricing — Not publicly available
DeploymentOn-premise (CT scanner), also available in modular or mobile setups
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

The Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i received 510(k) clearance (K192832) from the FDA on February 21, 2020. It is indicated to acquire and display cross-sectional volumes of the whole body, including the head, utilizing AiCE-i as a noise reduction algorithm employing Deep Convolutional Neural Network methods.
Integrations
EHR Not specified
Specialties Cardiology, Oncology, Radiology

What the Web Says

The Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i is a CT scanner that utilizes Deep Learning Reconstruction (AiCE-i) to enhance image quality, reduce noise, and optimize radiation dose across various clinical applications, including cardiology, oncology, and emergency medicine. It is designed for large-scale hospital and imaging center environments, offering robust on-premise deployment. The device received FDA clearance in February 2020.

Overall: Positive

Strengths

  • Superior image quality and noise reduction due to AiCE-i deep learning reconstruction.
  • Dose optimization across a broad spectrum of clinical applications.
  • Enhances diagnostic confidence in cardiology, oncology, and emergency medicine.
  • Versatile and high-performance CT scanner suitable for diverse patient populations and complex cases.
  • Robust on-premise deployment, designed for large-scale hospital and imaging center environments.
  • Proven track record in enterprise infrastructure from a well-established medical systems corporation (Canon).

Limitations

  • Pricing information is not publicly available, requiring direct vendor contact.
  • BAA (Business Associate Agreement) availability is unknown.
  • HIPAA compliance status is unknown.
  • No public ratings available on some review platforms.

Based on reviews from: Physician AI Tools, Canon Medical Systems, Innolitics, U.S. Food & Drug Administration

Last updated: 2026-07-18

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Press & Coverage

Innolitics
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i Cleared Traditional
The Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i received traditional clearance on February 21, 2020, as a computed tomography x-ray system. This device is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
2020-02
FDA
510(k) Premarket Notification - Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
Canon Medical Systems Corporation's Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i received 510(k) clearance from the FDA on February 21, 2020. The device is a 40-row CT System intended to acquire and display cross-sectional volumes of the whole body, including the head, and utilizes AiCE (Advanced intelligent Clear-IQ Engine) for noise reduction and improved image quality.
2020-02
Physician Ai Tools
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i vs uMI Panvivo
This comparison highlights the Aquilion Prime SP as a CT scanner with Deep Learning Reconstruction (AiCE-i) for superior image quality and dose optimization, ideal for detailed cardiac studies and artifact reduction. It features a 40-row CT system, expandable to 80 rows, with 160 slices per rotation and a 0.35-second scanning speed.
unknown
FDA
K192832 - 510(k) Premarket Notification
This FDA document lists Canon Medical Systems Corporation as the applicant for the Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i, with a regulation number of 892.175023 and product code JAK. The document confirms the device's regulatory information and contacts.
2026-06
Canon Medical Systems
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i | Canon Medical...
The Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i is an FDA-cleared radiology AI listing specifically for CT/CTA imaging. It is developed by Canon Medical Systems Corporation.
unknown
FDA-cleared directory
CT/CTA radiology AI tools | FDA-cleared directory
The Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i from Canon Medical Systems Corporation is listed in an FDA-cleared directory for CT/CTA radiology AI tools. Its decision date for clearance was February 21, 2020.
2020-02
unknown
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i (K192832...
This entry confirms the device name Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i, its record ID K192832, and Canon Medical Systems Corporation as the applicant. The product code is JAK.
unknown
FDA.report
CANON INC. FDA Filings
Canon Inc.'s FDA filings include the Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i, which received clearance on February 21, 2020, under 510(k) number K192832. This indicates its regulatory approval for market.
2020-02

Videos

Product demos, reviews, and walkthroughs for Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i.

View all on YouTube

Frequently Asked Questions

AiCE-i utilizes a Deep Convolutional Neural Network (DCNN) to differentiate signal from noise, resulting in significantly improved low-contrast detectability, noise reduction, and spatial resolution compared to traditional iterative reconstruction methods. This technology delivers sharp, clear, and distinct images at potentially lower radiation doses, thereby enhancing diagnostic confidence.
The Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i received U.S. FDA 510(k) clearance on February 21, 2020, classifying it as a Class II computed tomography x-ray system. Compliance involves adhering to general controls provisions, including device registration, listing, good manufacturing practices, and proper labeling.
AiCE-i, as Canon Medical's Deep Learning Reconstruction (DLR) technology, is trained on vast amounts of high-quality data to optimize noise reduction and signal enhancement. Studies indicate AiCE can offer lower noise and higher detectability compared to hybrid iterative reconstruction algorithms like AIDR 3D. While specific direct comparisons to all competitors are complex, DLR algorithms generally aim to overcome limitations of older iterative methods, though differences in noise texture and performance at very low doses can exist between vendors.
Direct pricing details for the AiCE-i feature are not publicly disclosed, as it is integrated into the Aquilion Prime SP system. Canon Medical Systems states that AiCE-i has been integrated into existing Prime SP hardware in a 'smart, cost-efficient way,' suggesting it's part of the overall system's value proposition rather than a separately itemized cost. The Aquilion Prime SP is positioned as an economic choice from installation through department expansion.
Like all AI reasoning models, AiCE-i's performance is dependent on the quality and scope of its training data, meaning biased or incomplete datasets could lead to skewed results. One study noted that while AiCE improved noise and contrast-to-noise ratios in brain CT, it showed a higher artifact index in the posterior cranial fossa compared to an iterative reconstruction algorithm. Physicians should always apply clinical judgment, especially in complex pathologies or specific patient populations.
AiCE-i is trained in a factory setting using high-quality, real patient datasets that are extensively processed with advanced reconstruction methods, with no off-site unsupervised training that could alter its performance. General best practices for AI systems, which Canon Medical Systems (Toshiba) adheres to, include implementing robust device and access security, encryption, tokenization, data masking, and compliance with regulations like HIPAA to protect patient data.
AiCE-i is designed for seamless integration into routine clinical practice and aims to simplify complex tasks for technologists with fast reconstruction speeds. While the system is built for ease of use, effective utilization of any new AI technology typically benefits from targeted training sessions focused on practical applications and best practices to ensure staff proficiency and reduce potential anxiety associated with new technology.

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