Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
Canon Medical Systems CorporationThe Aplio i900, i800, and i700 Software V8.1 Diagnostic Ultrasound System by Canon Medical Systems is an advanced ultrasound imaging platform. It provides high-quality ultrasound images across a variety of clinical applications, including fetal, abdominal, cardiac, musculoskeletal, and more. The system includes advanced imaging modes such as Doppler and elastography, and new AI-based features like Left Atrial Appendage analysis to improve diagnostic accuracy and workflow efficiency.
Intended Use
The Diagnostic Ultrasound System Aplio i900, i800, and i700 Software V8.1 are indicated for visualization and dynamic process imaging of human body structures using ultrasound across multiple clinical applications including fetal, abdominal, cardiac, musculoskeletal, thoracic, pleural, and gastrointestinal imaging.
Technology
The device employs various ultrasonic probes including flat linear array, convex, and sector array with frequency ranges between approximately 2 MHz to 33 MHz. It supports multiple imaging modes such as B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler, Power Doppler, Speckle-tracking, Tissue Harmonic Imaging, Shear wave Elastography, and Acoustic attenuation mapping. It also integrates new AI features like Left Atrial Appendage analysis and Strain Ratio Measurement to enhance diagnostic capabilities.
Performance
Comprehensive performance testing including clinical studies and phantom tests demonstrated the device meets specifications for new and improved features. Clinical evaluation of Left Atrial Appendage Analysis with 10 in-vivo datasets showed workflow improvement and measurement utility for planning. Strain Ratio Measurement testing with elasticity phantoms confirmed accuracy. The device meets applicable IEC standards and cybersecurity requirements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/28/2023
3 months - 2
FDA Approval
1/24/2024
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