Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A
Canon Medical Systems CorporationThe Aquilion ONE with Spectral Imaging System is a whole body multi-slice helical CT scanner that captures high-resolution cross-sectional images of organs like brain, heart, and pancreas. It employs advanced AI-based reconstruction (PIQE) to enhance image quality and reduce noise, especially for cardiac applications. The accompanying Vitrea Software Package provides advanced imaging analysis applications, including spectral CT analysis, coronary artery analysis, and visualization tools assisting clinicians in diagnosis and treatment planning.
Intended Use
The device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head, with capability to image whole organs in a single rotation. The software package allows processing, analysis, communication, and media interchange of multi-dimensional imaging data from various devices with specialized applications.
Technology
The system is a whole body multi-slice helical CT scanner utilizing two scan modes: spectral imaging scan and dual energy scan with rapid kV switching or dual tube rotations. AI-enabled reconstruction (PIQE) employs Deep Convolutional Neural Networks to enhance spatial resolution and reduce noise. The software includes various modules for organ-specific imaging and analysis accommodating CT, MR, X-ray angiography, and ultrasound data.
Performance
Bench testing with phantoms assessed CT image quality metrics demonstrating substantially equivalent or improved performance compared to predicate device. Tests included spatial resolution, noise reduction, contrast-to-noise ratio, and low contrast detectability. Clinical images reviewed by radiologists confirmed diagnostic image quality. Software validation was performed for AI reconstruction algorithm.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/1/2021
7 months - 2
FDA Approval
6/16/2022
Other devices from Canon Medical Systems Corporation
- Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)2024 • 510K
- Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR2024 • 510K
- Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR2024 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.