Tustin, Calif., November 26th, 2025 — Canon Medical Systems USA, Inc. recently received FDA 510(k) clearance for its Aplio i-series diagnostic ultrasound systems (Aplio i900, Aplio i800, and Aplio i700) with Software Version 9.0. This clearance introduces advanced imaging technologies designed to help clinicians achieve high-quality diagnostic images with greater efficiency.
The new software release includes three major innovations. First, 3rd Harmonic Imaging (3-HI) employs deep learning technology to filter and extract higher-order harmonic signals, producing ultrasound images with improved spatial and contrast resolution while reducing artifacts such as reverberation and sidelobes. This AI-powered feature is intended to deliver sharper, clearer images for improved diagnostic confidence.
Second, SMI Angio enhances Canon’s Superb Micro-vascular Imaging (SMI) technology by applying advanced statistical processing techniques to visualize microvascular flow with greater clarity. This improvement allows clinicians to more confidently evaluate tissue vascularity and branching patterns by distinctly delineating fine, closely spaced blood vessels.
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Third, Auto Tune Shear Wave automates transmit and receive settings based on tissue stiffness, streamlining workflow and supporting accurate elasticity measurements. By reducing manual adjustments, this feature is designed to improve efficiency and may contribute to more consistent shear wave exams, by reducing variation within the measurement region of interest (ROI).
“FDA clearance of these advanced features demonstrates Canon Medical’s commitment to innovation that supports clinicians in delivering high-quality care,” said Dan Skyba, Sr. Managing Director, UL Business Unit, Canon Medical Systems USA. “Canon is proud to be the first to apply an Altivity powered deep learning AI filter to enhance ultrasound image quality. We are raising the flag for innovation and driving the evolution of the harmonic imaging revolution in ultrasound. By integrating AI and automation, we’re empowering clinicians with tools that deliver clarity, efficiency, and confidence.”
Visit Canon Medical at RSNA 2025 to experience the future of ultrasound imaging. Explore the Aplio i-series innovations, including 3rd Harmonic Imaging powered by Altivity deep learning AI, SMI Angio mode, and Auto Tune Shear Wave mode, at Booth #7313 in Chicago, November 30 to December 4. Watch live demonstrations of our advanced AI workflow and discover how Canon is driving the evolution to revolution in diagnostic imaging.
