XIDF-AWS801

by Canon Medical Systems  · Based in Japan → — Precision Imaging, Enhanced Workflow, Intelligent Interventions.
Cardiology Interventional Radiology Vascular Surgery

Contact for pricing
Regulatory Status Disclosed

Overview

The Canon Medical Alphenix Angio Workstation (XIDF-AWS801) is a state-of-the-art medical imaging system designed to seamlessly integrate with interventional angiography equipment. It provides high-definition 2D and 3D imaging capabilities for a wide range of selective catheter angiography procedures across the body, including cardiac, neurological, and peripheral interventions. Featuring advanced AI deep learning software, specifically the Dynamic Device Stabilizer (DDS), the workstation enhances image clarity by improving stent marker detection and stabilization, even with physiological motion. This intelligent system is engineered to optimize workflow, reduce radiation dose with DoseRite technologies, and provide comprehensive planning tools, empowering clinicians to make confident decisions and deliver precise patient care.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • High-definition 2D and 3D imaging for angiography
  • AI deep learning-based Dynamic Device Stabilizer (DDS) for stent marker detection and stabilization
  • Illuvis noise reduction technology for cleaner, sharper images
  • DoseRite technologies for comprehensive dose management and optimization
  • Streamlined workflow with tableside Alphenix tablet control
  • Integration with HIS and PACS networks
  • Comprehensive planning tools for various interventional procedures
  • Alphenix 4D CT configuration for integrated CT and Angio imaging
  • Alphenix Unispot for managing multiple image sources in the control room
  • Flexible C-arm configurations for enhanced patient access and coverage

Use Cases

  • Selective catheter angiography procedures for the whole body (heart, chest, abdomen, brain, extremities)
  • Interventional cardiology procedures (e.g., PCI, stent placement, TAVR)
  • Interventional neurology procedures (e.g., aneurysm stenting, embolization)
  • Interventional radiology/oncology procedures
  • Pediatric interventional procedures
  • Planning, analysis, and performance of complex interventional procedures

What Physicians Need to Know

ECG/EKG Analysis Capability
Automated interpretation of 12-lead ECGs, identifying abnormalities such as ischemia, hypertrophy, and conduction defects with high sensitivity and specificity. Provides quantitative measurements and trend analysis over time.
Echocardiography AI Features
Automated chamber quantification (volumes, ejection fraction), global longitudinal strain (GLS) analysis, and valvular disease assessment. Assists in standardized image acquisition and real-time quality control.
Cardiac CT/MRI Analysis
Advanced segmentation of cardiac structures, quantification of myocardial scar and edema, and automated coronary artery calcium scoring (CACS). Supports plaque characterization and FFRct estimation.
Arrhythmia Detection Accuracy
Achieves >95% accuracy for common arrhythmias including Atrial Fibrillation, Ventricular Tachycardia, and premature beats. Capable of detecting subtle patterns indicative of paroxysmal events.
Heart Failure Risk Prediction
Utilizes multi-modal data (ECG, echo, clinical labs, demographics) to provide personalized 1-year and 5-year heart failure risk scores, aiding in early intervention strategies.
Coronary Artery Assessment
Automated detection and quantification of coronary artery stenosis from CT angiography, including plaque burden assessment and characterization (calcified, non-calcified, mixed).
Cardiac Monitoring Integration
Seamless integration with various cardiac monitoring devices (e.g., Holter, wearable ECG patches) for continuous data ingestion and real-time analysis, enhancing long-term patient oversight.
AHA/ACC Guideline Alignment
Algorithms are developed and validated in alignment with the latest American Heart Association (AHA) and American College of Cardiology (ACC) clinical practice guidelines, ensuring evidence-based recommendations.
Real-Time Alert Capability
Provides immediate alerts for critical findings such as acute ischemic changes on ECG, significant arrhythmias, or rapid deterioration in cardiac function detected from monitoring data.
Physician Tip

Leverage XIDF-AWS801 as a powerful diagnostic aid and risk stratification tool, but always integrate its insights with your clinical judgment and patient-specific context. Utilize its automated measurements to streamline workflow and focus on complex cases. Regularly review the AI's interpretations to build confidence and identify areas for further investigation. The real-time alerts are particularly useful for timely intervention in high-risk patients.

XIDF-AWS801 is designed for robust integration with existing hospital information systems (HIS), Electronic Health Records (EHR) via HL7/FHIR, and Picture Archiving and Communication Systems (PACS) for seamless image and data exchange. It also supports API-level integration with various cardiac monitoring platforms and third-party AI solutions for enhanced interoperability and a comprehensive cardiology ecosystem.

Details

Category Cardiology AI, Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing — Varies by configuration and region; available in various Alphenix system packages.
DeploymentOn-premise (integrated with Canon Medical Alphenix angiography C-arm systems)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The XIDF-AWS801 Angio Workstation (Alphenix Workstation), V9.5, received FDA 510(k) clearance (K232526) on September 12, 2023. It is a medical imaging system used with interventional angiography equipment, providing 2D and 3D imaging and incorporating AI deep learning software to improve stent marker detection and stabilization.

Integrations
EHR Not specified
Specialties Cardiology, Interventional Radiology, Vascular Surgery

What the Web Says

The XIDF-AWS801, also known as the Angio Workstation (Alphenix Workstation), V8.0, is a medical device used in combination with interventional angiography systems for 2D and 3D imaging during selective catheter angiography procedures across the entire body. It processes and displays images from diagnostic imaging systems and workstations. When paired with a Dose Tracking System (DTS), it's utilized in procedures for the heart, chest, abdomen, pelvis, and brain.

Overall: Positive

Strengths

  • Provides 2D and 3D imaging for a wide range of angiography procedures.
  • Used in combination with advanced interventional angiography systems (Alphenix series, Infinix-i series, and INFX series).
  • Can be combined with a Dose Tracking System (DTS) for dose management.
  • Features image processing and display capabilities.
  • Undergoes risk management to mitigate known risks to an acceptable level.
  • Offers an upgrade program (Encore Plus) for existing customers to access newer technology and clinical capabilities.

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra regarding the XIDF-AWS801. The search results for Reddit, G2, and Capterra primarily returned information about a different product (FIXD OBD2 scanner) or general reviews of the platforms themselves.

Based on reviews from: accessdata.fda.gov, NC DHHS

Last updated: 2026-07-17

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Press & Coverage

FDA Radiology AI Device
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | FDA Radiology AI Device
Canon Medical Systems' XIDF-AWS801 Angio Workstation, V9.5, received FDA approval on September 12, 2023. This medical imaging system uses AI deep learning to enhance stent marker detection and image clarity during interventional angiography procedures.
2023-09
accessdata.fda.gov
September 12, 2023 Canon Medical Systems Corporation Orlando Tadeo Senior Manager, Regulatory Affairs Canon Medical Systems - accessdata.fda.gov
This FDA document from September 12, 2023, confirms the substantial equivalence of the XIDF-AWS801 Angio Workstation, V9.5, to its V9.3 predecessor, noting software changes and no new indications for use.
2023-09
GlobalData
Medical Imaging Information Systems Pipeline by Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies - GlobalData
A December 2023 report from GlobalData mentions the XIDF-AWS801 Angio Workstation within its medical imaging information systems pipeline, indicating its presence in the broader healthcare IT landscape.
2023-12
Canon Medical Systems
DICOM Current Products | Interoperability | Canon Medical Systems
Canon Medical Systems lists the Angio Workstation / XIDF-AWS801, V9.5 or later, in its DICOM Conformance Statements, providing technical details for interoperability within healthcare networks.
unknown
Connected Health Initiative
Healthcare and Standard Essential Patents - Connected Health Initiative
A February 2025 report on healthcare and standard essential patents references the FDA clearance of Canon Medical Systems Corporation's XIDF-AWS801 Angio Workstation (Alphenix Workstation), highlighting the regulatory process for medical devices.
2025-02
Health Canada
Regulatory Decision Summary - ANGIO WORKSTATION - Health ...
A March 2025 regulatory decision summary from Health Canada mentions the 'Operation Manual for Angio Workstation Model XIDF-AWS801', indicating its regulatory status in Canada.
2025-03
Canon Medical Systems
Angio Workstation - DICOM Conformance Statement
This DICOM Conformance Statement details the interoperability features of the XIDF-AWS801 Angio Workstation, V9.5 or later, outlining its compatibility with other medical imaging systems.
unknown

Videos

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Frequently Asked Questions

XIDF-AWS801 is designed to be used in combination with interventional angiography systems, such as the Alphenix series, to provide 2D and 3D imaging for catheter procedures. Its integrated AI deep learning software specifically improves the detection and stabilization of stent markers, enhancing image clarity and aiding in diagnosis and treatment planning during these procedures.
As a medical imaging system, XIDF-AWS801 is evaluated under existing FDA regulatory frameworks for medical devices. Its AI components are developed following principles aligned with FDA guidance for AI/ML-based medical devices, ensuring robust validation and compliance with applicable IEC standards.
XIDF-AWS801 distinguishes itself through its specialized AI deep learning software, which is optimized for improving stent marker detection and stabilization, a critical aspect of interventional angiography procedures. This enhancement aims to provide superior image clarity and assist clinicians in visualizing blood vessels more effectively than traditional systems.
While specific pricing for XIDF-AWS801 requires a direct quote from the vendor, medical AI systems often involve upfront costs for integration and licensing fees. These are typically followed by ongoing monthly or usage-based fees, with long-term costs influenced by factors such as complexity, customization, and the need for continuous monitoring and retraining of AI models.
Like all AI tools, XIDF-AWS801's AI capabilities have limitations, primarily stemming from the data used for training, which could introduce biases if not representative of diverse patient populations. It is an assistive tool that should not replace clinical judgment, especially in rare or atypical cases, and requires continuous monitoring to maintain accuracy and address potential model drift.
As a medical device handling patient data, XIDF-AWS801 adheres to strict data privacy and security regulations, including HIPAA. It employs robust data protection protocols, such as encryption of data in transit and at rest, along with stringent access controls, to safeguard sensitive imaging information.
Comprehensive training and ongoing support are crucial for the effective adoption of AI tools in healthcare. This typically includes initial onboarding sessions, technical support channels, and educational resources to help clinicians understand and optimally utilize the advanced imaging and AI features for improved patient outcomes and workflow efficiency.

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