Aplio i900/i800/i700 Diagnostic Ultrasound System

by Canon Medical Systems Corporation  · Based in Japan → — Experience sharper imaging, smarter automation, and deeper clinical insights.
Cardiology Obstetrics & Gynecology Radiology

Regulatory Status Disclosed

Overview

The Aplio i900/i800/i700 Diagnostic Ultrasound System is a premium, mobile diagnostic ultrasound platform manufactured by Canon Medical Systems. It is designed to deliver outstanding clinical precision and departmental productivity across a wide range of clinical applications. This system is *not* an AI tool for a physician directory, but rather a sophisticated medical imaging device that incorporates advanced AI-assisted features to enhance diagnostic capabilities and streamline workflows. The Aplio i-series utilizes technologies like iBeam+ architecture, intelligent Dynamic Micro-Slice (iDMS), and ultra-wideband transducers to provide crystal-clear images with enhanced resolution and penetration. It integrates AI-driven functions for improved image quality, automated measurements, and workflow efficiency, supporting clinicians in making confident diagnostic decisions.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-assisted productivity and imaging functions (Altivity AI brand)
  • Deep Learning-empowered Smart Area Indication for OB
  • Automated contour tracing powered by AI for workflow consistency
  • 3rd Harmonic Imaging (3-HI) with deep learning for improved spatial and contrast resolution
  • Superb Micro-vascular Imaging (SMI) and SMI Angio for enhanced blood flow visualization
  • Shear Wave Elastography and Attenuation Imaging (ATI) for tissue stiffness and viscosity assessment
  • iBeam+ technology for advanced B-mode image quality and higher frame rates
  • Intelligent Dynamic Micro-Slice (iDMS) matrix technology for sharpened ultrasonic beams
  • Ultra-wideband, multi-frequency transducers for superior sensitivity and resolution
  • Automated measurement and analysis tools (e.g., Auto Plane Detection, Quick Strain, Auto Doppler Trace)

Use Cases

  • Abdominal imaging and liver analysis
  • Cardiac imaging (adult and pediatric) and wall motion assessment
  • Musculoskeletal imaging (conventional and superficial)
  • Fetal and Women's Health imaging, including assisted reproduction
  • Small organs imaging (thyroid, breast, testicle)
  • Image-guided interventions

What Physicians Need to Know

Evidence Base
The Aplio i-series leverages advanced imaging modes such as Shear Wave Elastography (SWE), Attenuation Imaging (ATI), and Contrast-Enhanced Ultrasound (CEUS), which are founded on established clinical principles and supported by research. The system integrates reporting tools based on recognized clinical guidelines, including BI-RADS and TI-RADS for standardized lesion characterization, and provides workflow support aligned with American Society of Echocardiography (ASE) and American College of Radiology (ACR) guidelines.
Clinical Validation Studies
Clinical testing has validated key features, such as Left Atrial Appendage (LAA) Analysis, demonstrating improved workflow. AI-powered features like Auto Plane Detection and Quick Strain have shown high accuracy (e.g., >90% agreement for cardiac view detection, 97% accuracy for Auto Plane Detection) and significant workflow efficiency improvements (e.g., up to 78% reduction in operation time, 68% reduction in LV strain measurement time). Performance testing, including validation on independent clinical datasets, confirms substantial equivalence to predicate devices. Studies also compare the diagnostic performance of its 2D-SWE for liver stiffness assessment.
Differential Diagnosis Support
While not a traditional differential diagnosis engine, the system provides high-quality images and quantitative data (e.g., tissue stiffness, attenuation coefficients, perfusion dynamics) that are crucial for aiding physicians in differential diagnosis. Features like multi-parametric reports for liver analysis can combine ultrasound results with external exam data for a more comprehensive diagnostic picture. Integrated BI-RADS and TI-RADS tools standardize lesion description and reporting, indirectly supporting diagnostic pathways.
Guideline Update Frequency
The system's software undergoes regular updates (e.g., Software Version 8.1, 9.0) that introduce new features, enhance existing capabilities, and improve image quality and workflow efficiency. These updates implicitly align the system's diagnostic tools with evolving clinical best practices and guidelines. Integrated reporting tools based on guidelines like BI-RADS, TI-RADS, ASE, and ACR are updated to reflect current clinical standards.
Clinical Workflow Integration
The Aplio i-series is designed for enhanced productivity and streamlined workflows. Features like 'Workflow Navigator' provide reporting support based on clinical guidelines. AI-based tools such as Auto Plane Detection, Auto LVOT, Auto AoV, and Quick Strain automate measurements and reduce scanning time, significantly improving efficiency. The system supports multi-parametric reports that can integrate ultrasound findings with external clinical data, customizable to facility protocols. Ergonomic design with features like FleXstyle and Ultra-Wide View further optimizes the user experience and diagnostic confidence.
Decision Audit Trail
The system facilitates documentation of the diagnostic process by allowing saving of measurement data and generation of comprehensive reports. Multi-parametric reports can combine results from various ultrasound applications and external exams, providing a detailed record of the patient's examination status and supporting follow-up. This robust reporting capability serves as a critical component of the clinical audit trail.
Physician Tip

To maximize the diagnostic utility of the Aplio i-series, physicians should leverage its advanced quantitative tools like Shear Wave Elastography and Attenuation Imaging for precise tissue characterization, especially in liver assessment. Utilize the AI-powered features such as Auto Plane Detection and Quick Strain to streamline cardiac exams and improve measurement consistency. Embrace the integrated reporting tools (BI-RADS, TI-RADS) for standardized lesion description and efficient communication. The system's ability to combine multi-parametric data in reports offers a holistic view, enhancing diagnostic confidence and supporting comprehensive patient management.

The Aplio i-series is built for seamless integration into existing clinical environments. It supports DICOM standards for image and data transfer, enabling connectivity with Picture Archiving and Communication Systems (PACS) and Electronic Medical Records (EMR). Its structured reporting capabilities, including multi-parametric reports, facilitate efficient data exchange and comprehensive documentation within the hospital's information systems.

Details

Category Clinical Decision Support & Reference, Radiology & Imaging AI
Pricing Unknown
DeploymentOn-premise (mobile diagnostic ultrasound system)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Aplio i900/i800/i700 Diagnostic Ultrasound System, including Software V7.0 (K241582), V8.1, and V9.0, has received FDA 510(k) clearance for visualizing structures and dynamic processes within the human body for diagnosis in various clinical applications.

Integrations
EHR Not specified
Specialties Cardiology, Obstetrics & Gynecology, Radiology

What the Web Says

The Canon Medical Aplio i-series (i900/i800/i700) Diagnostic Ultrasound System is generally well-regarded by physicians and healthcare professionals for its advanced imaging capabilities and user-friendly design. It offers high-quality ultrasound images across various modes and clinical applications, with continuous innovation through software updates and new transducers. The system is particularly praised for its detailed visualization, diagnostic confidence, and efficient workflow.

Overall: Positive

Strengths

  • High-quality ultrasound images with excellent resolution, detail, and clarity.
  • Advanced imaging technologies including 3rd Harmonic Imaging (3-HI) with deep learning, SMI Angio, and Attenuation Imaging (ATI).
  • Comprehensive suite of liver analysis tools.
  • User-friendly workflow and intuitive controls, allowing for quick optimization and customization.
  • Versatile for a wide range of clinical applications, including vascular, abdominal, cardiac, and musculoskeletal imaging.
  • Scalable solution with a compact and flexible design, including console height adjustment and articulating arms.

Limitations

  • Lack of post-processing features compared to some competitors like GE.
  • One reported recall in 2018 for a power supply unit issue that could prevent startup if the main power switch was on during plug-in (since terminated).

Based on reviews from: Innolitics, Canon Medical Systems USA, Inc., Vertex AI Search, FirstWord HealthTech, YouTube (Dr. Bartlett - User Experience - Canon UL Aplio i-series/Prism Edition), accessdata.fda.gov, Medevx, Sono Solutions, YouTube (The Aplio i800 Ultrasound System: Delivering Resolution, Detail & Clarity), Reddit (r/Sonographers), Olympus Corporation, PRNewsfoto/Olympus Medical Systems Group

Last updated: 2026-07-20

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Press & Coverage

Medevx
Aplio i900, Aplio i800, and Aplio i700 Software V8.1 Diagnostic Ultrasound System
This regulatory announcement details the FDA clearance of the Aplio i900, i800, and i700 Diagnostic Ultrasound System with Software V8.1, which includes new features like Left Atrial Appendage Analysis and expanded transducer support. The updated system offers enhanced diagnostic capabilities for cardiac analysis and gastrointestinal imaging.
2024-10
X-ray Interpreter
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) | FDA Radiology AI Device - X-ray Interpreter
This article discusses the FDA approval of the Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0, highlighting its advanced imaging modes and AI-based improvements for enhanced workflow efficiency and diagnostic accuracy in various clinical applications. The system includes features like Auto Plane Detection and Quick Strain.
2024-09
FDA
K241582 - 510(k) Premarket Notification - FDA
This FDA 510(k) Premarket Notification details the Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0, submitted by Canon Medical Systems Corporation. It provides regulatory information and contact details for the applicant and correspondent.
2025-12
X-ray Interpreter
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 | FDA Radiology AI Device - X-ray Interpreter
This article describes the Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5, by Canon Medical Systems, highlighting its advanced imaging modes and support for various clinical applications. The system provides high-quality images and workflow improvements for enhanced diagnostic capabilities.
2025-05
MDPI
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting - MDPI
This peer-reviewed article includes the Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (K241582) in its analysis of machine learning-enabled medical devices authorized by the FDA in 2024. It examines regulatory characteristics, predicate lineage, and transparency reporting for these devices.
2025-12
X-ray Interpreter
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 | FDA Radiology AI Device - X-ray Interpreter
This article details the Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5, by Canon Medical Systems Corporation, emphasizing its high-quality diagnostic capabilities and suitability for various clinical applications. It supports multiple ultrasound modes and AI-supported functions for enhanced image quality and workflow.
2022-01
Innolitics
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (K223017) - Innolitics
This document from Innolitics provides details on the FDA's 510(k) premarket notification for the Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0. It confirms the device's substantial equivalence to predicate devices and outlines its indications for use in various clinical applications.
2023-03
unknown
Canon Aplio i900/i800/i700 Ultrasound System Software V8.1 510(k) Submission
This 510(k) submission outlines the Canon Aplio i900/i800/i700 Diagnostic Ultrasound System Software V8.1, detailing its indications for use in various clinical applications and its high-quality ultrasound imaging modes. It also mentions the system's suitability for hospital and clinical settings.
2024-01

Videos

Product demos, reviews, and walkthroughs for Aplio i900/i800/i700 Diagnostic Ultrasound System.

View all on YouTube

Frequently Asked Questions

The Aplio i-series integrates AI features like 3rd Harmonic Imaging (3-HI) for sharper images with reduced artifacts and enhanced tissue detail, and SMI Angio for superior microvascular flow visualization, boosting diagnostic confidence. AI also streamlines workflow through automated routine measurements and Smart Area Indication for OB applications, which helps identify standard anatomical views and improves exam uniformity. These AI-assisted productivity functions, powered by Canon's Altivity brand, aim to deliver faster, more accurate results and enable personalized patient care.
The AI features within the Aplio i-series systems, such as 3rd Harmonic Imaging and SMI Angio, have received FDA 510(k) clearance for their intended diagnostic use. The systems also hold CE Mark approvals in European regions. Canon Medical generally adheres to stringent regulatory requirements, including the Quality System (QS) regulation, and emphasizes cybersecurity and secure data handling practices to ensure data privacy and compliance with healthcare regulations.
Physicians considering the Aplio i-series for its advanced AI capabilities might also evaluate high-end ultrasound systems from competitors such as GE Healthcare, including their Logiq E10s and Voluson Expert series, and Philips' EPIQ Elite systems. Siemens Healthineers offers the Acuson Sequoia, Redwood, and Juniper lines with AI capabilities, while Samsung's HERA and RS85 Prestige series also provide advanced imaging and AI-enabled tools.
The pricing for Aplio i-series systems varies significantly based on configuration, included transducers, and specific AI packages. Refurbished Aplio i800 systems, for example, can range from approximately $25,000 to over $60,000. While core AI features are often integrated, advanced functionalities or future software updates may involve additional licensing or service agreements, which are typically managed through Canon Medical's service agreements.
Like all AI in medical imaging, the algorithms in the Aplio i-series are subject to limitations such as operator dependency and image variability, which can affect data completeness and consistency. AI is designed as an assistive tool to enhance workflow and provide quantitative analysis, not to replace a physician's clinical judgment. Canon Medical addresses this by ensuring AI algorithms are trained at the factory for consistent behavior, emphasizing that physicians must always interpret results within the clinical context to mitigate potential biases or false positives.
The Aplio i-series systems are designed for seamless integration with existing hospital IT infrastructure, including PACS and EMR systems, by embracing standardized data formats like DICOM and HL7. This allows for efficient transfer of images, measurements, and AI-generated structured reports. The systems also offer embedded raw data functionality for post-processing and analysis, and options for secure local network storage.
Canon Medical provides comprehensive training and ongoing support to ensure effective utilization of the Aplio i-series' advanced AI features. This includes access to the Canon Medical Academy USA, offering expert-led online education, live, and on-demand courses, as well as onsite training. Additionally, ongoing technical support, software updates, and clinical application specialists are available to assist physicians and sonographers in maximizing the system's capabilities and maintaining proficiency.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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