Aquilion Serve SP (TSX-307B/1)

by Canon Medical Systems Corporation  · Based in Japan → — Simply performs. Delivering clinical results with innovative solutions.
Cardiology Oncology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

The Aquilion Serve SP (TSX-307B/1) is a cutting-edge Computed Tomography (CT) system from Canon Medical Systems, designed to enhance clinical confidence, patient experience, and operational efficiency in radiology departments. This whole-body multi-slice helical CT scanner integrates advanced AI-enabled technologies and automated workflows to deliver high-quality, low-dose imaging for a wide range of clinical applications.

Key to its performance is the **Advanced intelligent Clear-IQ Engine (AiCE) Deep Learning Reconstruction (DLR)**, which is AI-trained for all body regions. AiCE provides sharp, clear, and distinct images, improving spatial resolution and reducing noise, thereby enhancing the ability to detect subtle pathology and resolve fine structures. The system also features **INSTINX AI-assisted workflow automation**, a redesigned total workflow experience that streamlines operations, reduces workflow steps by up to 40%, and ensures consistent results regardless of operator experience.

Patient comfort and safety are prioritized with a wide, open, and flared 80 cm gantry, a wide and comfortable 47 cm table, and a low table height of 33 cm for improved access. Built-in positioning cameras and gantry touch panels facilitate quick and accurate patient setup. The **SilverBeam Filter** enables ultra-low dose scanning, optimized for applications like Lung Cancer Screening, by selectively removing low-energy photons.

Additional innovative features include **3D Landmark Scan** with AI-enabled Anatomical Landmark Detection (ALD) for precise scan planning, and **SEMAR (Single Energy Metal Artefact Reduction)** technology to reduce metallic artifacts, improving visualization around implants. The Aquilion Serve SP is equipped with an 80-row PUREVision detector, a 0.35-second rotation speed, and a 72 kW generator, supporting robust cardiac CT examinations with the **SURECardio engine**.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AiCE Deep Learning Reconstruction (DLR)
  • INSTINX AI-assisted workflow automation
  • SilverBeam Filter for ultra-low dose scanning
  • 80 cm wide-bore gantry for patient comfort
  • Built-in positioning cameras and gantry touch panels
  • Tech Assist Lateral Slide
  • 3D Landmark Scan with Anatomical Landmark Detection (ALD)
  • PUREVision detector (80 rows, 0.5 mm)
  • 0.35 sec rotation speed
  • SURECardio engine for robust cardiac imaging
  • SEMAR (Single Energy Metal Artefact Reduction)
  • Compact design for easy installation

Use Cases

  • Routine and complex CT imaging
  • Pediatric, bariatric, and cardiac exams
  • Lung cancer screening
  • Trauma and oncology settings
  • CT-guided interventional procedures
  • Post-surgical imaging with metal artifact reduction

What Physicians Need to Know

DICOM Support & Standards
The Aquilion Serve SP (TSX-307B) iSeries V1.3 or later provides DICOM Conformance Statements, ensuring compatibility with standard DICOM protocols for hospital network integration.
PACS Integration Method
Integration with Picture Archiving and Communication Systems (PACS) is achieved through standard DICOM protocols. Additionally, it seamlessly integrates with Vitrea Advanced Visualization, a separate Canon product, for advanced post-processing and analysis, which then likely connects to PACS.
Reading Room Workflow Impact
Features an 'INSTINX' AI-assisted total workflow experience, which includes automated protocol setup, automated scanner workflow, remote scan support, and zero-click post-processing. This leads to a 40% reduction in workflow steps and 97% accuracy in scan range planning with Anatomical Landmark Detection (ALD), improving efficiency, consistency, and throughput.
AI Model Architecture (deep learning approach)
Utilizes 'AiCE (Advanced intelligent Clear-IQ Engine)', a Deep Learning Reconstruction (DLR) algorithm employing Deep Convolutional Neural Network methods for noise reduction and image quality enhancement. It also features Precise IQ Engine (PIQE) DLR for super-resolution 1024 matrix images, both powered by Altivity, Canon Medical's overarching AI brand.
Processing Speed (per study)
Offers a reconstruction speed of up to 70 frames per second (fps) for helical scans.
FDA Clearance Pathway (510k/De Novo)
The Aquilion Serve SP (TSX-307B/1) V1.3 received 510(k) clearance under K233334.
Supported Modalities
This is a whole-body multi-slice helical Computed Tomography (CT) scanner, indicated for acquiring and displaying cross-sectional volumes of the entire body, including the head.
Sensitivity & Specificity Data
While specific sensitivity and specificity data for clinical applications are not explicitly detailed, objective image quality evaluations using phantoms were performed to assess metrics such as Contrast-to-Noise Ratios (CNR), CT Number Accuracy, Uniformity, MTF, SD of Noise, NPS, and Low Contrast Detectability (LCD). AiCE is noted to improve the ability to detect subtle pathology and resolve fine structures.
RSNA/ACR Validation
The Aquilion Serve SP was unveiled at RSNA 2023, where Canon Medical Systems highlighted its AI-enabled technologies, including the integration of AiCE across its CT portfolio.
Physician Tip

Physicians can anticipate high-quality, low-dose imaging across various anatomical regions, including cardiac, abdomen, pelvis, lung, extremities, head, and inner ear, thanks to AiCE Deep Learning Reconstruction and SilverBeam technology. The AI-assisted workflow, INSTINX, promotes consistent image quality and reduced variability across operators, potentially leading to faster and more confident diagnoses. Enhanced visualization, particularly for lung cancer screening and metal artifact reduction, is also a key benefit. The system's automation aims to streamline the entire CT examination process, from patient positioning to post-processing.

The Aquilion Serve SP ensures standard integration into existing hospital networks and PACS through its DICOM conformance. For advanced image analysis, it seamlessly integrates with Canon's Vitrea Advanced Visualization. The INSTINX workflow solution provides end-to-end AI-assisted automation within the CT exam, and the Remote Assist feature allows for remote scanning support, enhancing care delivery and productivity.

Details

Category Radiology & Imaging AI
Pricing Contact for pricing
DeploymentOn-premise
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

The Aquilion Serve SP (TSX-307B/1) V1.3 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 received 510(k) clearance (K233334) on December 6, 2023, and is equipped with a SilverBeam Filter and AiCE (Advanced Intelligent Clear-IQ Engine) for improved image quality and dose reduction.

Integrations
EHR Not specified
Specialties Cardiology, Oncology, Radiology

What the Web Says

The Aquilion Serve SP (TSX-307B/1) is a whole-body multi-slice helical CT scanner from Canon Medical Systems, cleared by the FDA in late 2023. It's designed for various specialized studies, including head, brain, heart, and lung imaging. The system incorporates advanced technologies like the AiCE (Advanced Intelligent Clear-IQ Engine) noise reduction algorithm and a SilverBeam Filter to enhance image quality and reduce radiation dose.

Overall: Positive

Strengths

  • Improved image quality through AiCE (Advanced Intelligent Clear-IQ Engine) noise reduction algorithm.
  • Reduced radiation dose with the SilverBeam Filter and specialized dose reduction modes.
  • Enhanced performance and efficiency due to a 7.5 MHU X-ray tube, allowing for higher power and longer usage between cooling cycles.
  • Capability to acquire and display cross-sectional volumes of the whole body, including whole organs in a single rotation.
  • CLEAR Motion algorithm improves diagnostic image quality in lung CT imaging by reducing motion artifacts.
  • PIQE algorithm ensures consistent CT value accuracy and noise performance for cardiac, body, and lung scans.

Limitations

  • Limited availability of direct physician or tech reviewer opinions and detailed user experiences in the search results.
  • No specific reviews found on platforms like Reddit, G2, or Capterra.
  • Information primarily from regulatory documents and product pipeline analyses, not independent user reviews.

Based on reviews from: FDA-cleared listings - Radiology AI Tools Directory, FDA Clearance for Aquilion Serve SP | PDF | Federal Food - Scribd, Canon Medical Systems Corp - Product Pipeline Analysis, 2026 Update, accessdata.fda.gov

Last updated: 2026-07-18

Ratings & Reviews

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Press & Coverage

X-ray Interpreter
Aquilion Serve SP (TSX-307B/1) V1.3 | FDA Radiology AI Device - X-ray Interpreter
The Aquilion Serve SP (TSX-307B/1) V1.3 is a multi-slice helical CT scanner that received FDA approval on December 6, 2023. It features an AI-based noise reduction algorithm called AiCE to enhance image quality for various diagnostic applications.
2023-12
FDA
K233334 - 510(k) Premarket Notification - FDA
This document is the 510(k) Premarket Notification for the Aquilion Serve SP (TSX-307B/1) V1.3, submitted by Canon Medical Systems Corporation. It details the regulatory information and classification of the device.
2026-01
HaRi
HaRi u00b7 Aquilion Serve SP (TSX-307B/1) V1.3
This entry provides an overview of the regulatory registrations, clearances, and safety data for the Aquilion Serve SP (TSX-307B/1) V1.3 across various health authorities including FDA, MHRA, Health Canada, TGA, and EUDAMED.
unknown
FDA
December 6, 2023 Canon Medical Systems Corporation Orlando Tadeo Sr. Manager, Regulatory Affairs Canon Medical Systems, USA
This FDA document confirms the clearance of the Aquilion Serve SP (TSX-307B/1) V1.3 and details its device description, indications for use, and performance evaluation. The system includes a SilverBeam Filter for optimized X-ray spectrum and AiCE for noise reduction.
2023-12
FDA
March 13, 2026 Canon Medical Systems Corporation Yoshiaki Cook Sr. Manager, Regulatory Affairs Canon Medical Systems, USA 2 - accessdata.fda.gov
This FDA filing discusses the Aquilion Serve SP (TSX-307B) V2.0, an updated version of the CT scanner, detailing its indications for use and new reconstruction capabilities like CLEAR Motion and PIQE algorithms.
2026-03
GlobalData
Computed Tomography (CT) Systems Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies - GlobalData
This report from GlobalData includes the Aquilion Serve SP (TSX-307B/1) V1.3 CT Device within its pipeline analysis of computed tomography systems. It highlights the device's 510(k) clearance in December 2023.
2024-05
FDA
Establishment Registration & Device Listing - accessdata.fda.gov
This FDA listing confirms the registration of the Aquilion Serve SP (TSX-307B/1) V1.3 as an X-ray system.
2026-04
FDA.report
CANON INC. FDA Filings - FDA.report
This report lists FDA filings for Canon Inc., including the Aquilion Serve SP (TSX-307B/1) V1.3 with its classification and approval date in December 2023.
2023-12

Videos

Product demos, reviews, and walkthroughs for Aquilion Serve SP (TSX-307B/1).

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Frequently Asked Questions

The Aquilion Serve SP integrates AI-assisted features like INSTINX for automated protocol setup, scanner workflow, and patient triage, aiming to boost operational efficiency. It also utilizes AiCE (Advanced intelligent Clear-IQ Engine) Deep Learning Reconstruction to deliver sharp, clear images with reduced noise and lower radiation dose.
The Aquilion Serve SP (TSX-307B/1) V1.3 has received FDA 510(k) clearance (K233334), indicating it has been deemed substantially equivalent to previously cleared devices. It conforms to various international and national standards, including IEC and NEMA, and is subject to the Quality System (QS) regulation (21 CFR Part 820), ensuring its safety and effectiveness.
While the AI significantly enhances workflow and image quality, it functions as an assistive tool rather than a replacement for physician expertise. For instance, AI-enabled Anatomical Landmark Detection boasts 97% accuracy, implying a small margin for error that requires physician oversight. Additionally, some advanced post-processing applications, like Vitrea, may be separate purchases.
Specific pricing for the Aquilion Serve SP is not publicly listed, but new advanced CT models can range from $450,000 to over $2 million, placing this 'ultra-performance' system likely on the higher end. While direct comparisons are difficult without exact figures, other high-end CT systems from Canon and competitors like Siemens and GE offer varying price points based on features and capabilities.
Yes, other CT systems, including Canon's own Aquilion ONE series (e.g., Aquilion ONE/Insight Edition, Aquilion ONE/GENESIS Edition) and Aquilion Prime SP, offer advanced AI and Deep Learning Reconstruction technologies like AiCE and PIQE. Competitor models from Siemens and GE also feature their own AI-powered solutions for image quality and workflow optimization.
The Aquilion Serve SP utilizes AiCE Deep Learning Reconstruction to achieve high-quality images at ultra-low radiation doses, optimizing CT Lung Cancer Screening with technologies like SilverBeam. Furthermore, its CLEAR Motion Deep Learning Reconstruction method is designed to reduce motion artifacts, particularly in lung imaging, enhancing diagnostic confidence and patient safety.
The system is designed to meet diverse clinical needs, from routine to complex imaging, including pediatric, bariatric, and cardiac exams, with its AI-assisted workflow and reconstruction technologies. While the core AI features are integrated, the system's capability to provide volume sets for specialized studies, using indicated software/hardware, suggests adaptability for trained physicians.

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