Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
Canon Medical Systems CorporationThe Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i is a computed tomography (CT) scanner designed for whole body imaging, including the head. It incorporates an AI-driven image reconstruction algorithm called AiCE-i that reduces image noise and improves image quality by using deep convolutional neural networks. This enhancement supports clinicians by providing clearer, more detailed images with potentially lower radiation dose, facilitating better diagnosis and patient care.
Intended Use
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. AiCE (Advanced Intelligent Clear-IQ Engine) is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications.
Technology
The Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i is an 80-row CT system that is a whole body, multi-slice helical CT scanner. The system includes a gantry, couch, and console. It integrates AiCE-i, a reconstruction algorithm using Deep Convolutional Neural Network (DCNN) methods to reduce image noise and improve image quality, which is more advanced than previous AIDR 3D noise reduction technologies.
Performance
Performance testing included phantom-based image quality metrics measuring Contrast-to-Noise Ratio, CT Number Accuracy, Uniformity, Modulation Transfer Function, Noise Power Spectra, and Low Contrast Detectability. Results demonstrated that AiCE-i images are substantially equivalent or superior to the predicate device, with claims of up to 82.9% dose reduction relative to filtered backprojection, improved low contrast detectability by 15%, and noise reduction by 29% at the same dose for body imaging.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/2/2020
6 months - 2
FDA Approval
1/12/2021
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