Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
Canon Medical Systems CorporationThe Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 by Canon Medical Systems Corporation is a high-quality ultrasound imaging device designed for use in diverse clinical applications, such as cardiac, abdominal, musculoskeletal, fetal, and small organs imaging. It provides advanced imaging modes including Doppler, Harmonic Imaging, Elastography, and AI-based improvements like Auto Plane Detection and Quick Strain to enhance workflow efficiency and diagnostic accuracy for clinicians.
Intended Use
The Diagnostic Ultrasound System Aplio i900/i800/i700 are indicated for visualization of structures and dynamic processes of the human body using ultrasound, providing diagnostic images in multiple clinical applications such as fetal, abdominal, cardiac, musculoskeletal, and more.
Technology
The system is a mobile diagnostic ultrasound device supporting a wide range of probes and ultrasound imaging modes including Doppler and elastography. It includes AI-based features utilizing deep learning for automatic cardiac view detection (Auto Plane Detection), automated Doppler waveform tracing (Auto LVOT, Auto AoV), and enhanced wall motion tracking (Quick Strain).
Performance
Performance testing included validation on independent clinical datasets demonstrating substantial equivalence to predicate devices. AI features achieved high accuracy with over 90% agreement in automatic cardiac view detection, significant operation time reduction (up to 78%), and minimal variability across demographic subgroups for Doppler tracing and wall motion tracking.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/3/2024
3 months - 2
FDA Approval
9/12/2024
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