Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5
Canon Medical Systems CorporationThe Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 by Canon Medical Systems is a diagnostic ultrasound device that uses advanced imaging modes like Doppler, elastography, and speckle tracking to provide high-quality ultrasound images of various body parts including fetal, abdominal, cardiac, and musculoskeletal regions. It aids clinicians by providing detailed images to support diagnosis and clinical evaluation in hospitals and clinics.
Intended Use
The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 are indicated for visualization of structures and dynamic processes in the human body using ultrasound for diagnosis in multiple clinical applications such as fetal, abdominal, pediatric, cardiac, vascular, musculoskeletal, thoracic/pleural, and more.
Technology
These systems are mobile diagnostic ultrasound devices employing a wide array of probes including flat linear array, convex, and sector array with frequency ranges between approximately 2MHz to 33MHz. Imaging modes include B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler, Power Doppler, Combination Doppler, Speckle-tracking, Tissue Harmonic Imaging, Shear Wave, Elastography, Acoustic attenuation mapping, and 3D/4D imaging functionalities. They provide high-quality images and support various software workflow improvements for enhanced image quality and diagnostic capabilities.
Performance
Risk analysis, verification, and validation testing confirm the device meets specifications and functions safely and effectively. Additional performance testing was performed for new transducers and software functionality, supported by adherence to relevant IEC and ANSI standards. Cybersecurity and software documentation are provided in compliance with FDA guidance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/17/2024
7 months - 2
FDA Approval
5/13/2025
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