Aquilion Precision (TSX-304A/4) V10.14 with AiCE
Canon Medical Systems CorporationThe Aquilion Precision (TSX-304A/4) V10.14 with AiCE is an advanced whole-body CT scanner that leverages AI through deep convolutional neural networks to reduce image noise and improve image quality. It also uses an iterative reconstruction algorithm to reduce radiation dose while enhancing spatial resolution. This helps clinicians obtain clearer and more detailed images to support diagnosis and treatment planning across various body regions, including abdomen, chest, brain, and extremities.
Intended Use
This device is indicated to acquire and display cross-sectional volumes of the whole body, including the head. It can provide volume sets used to perform specialized studies by a trained and qualified physician.
Technology
An ultra-high resolution whole-body multi-slice helical CT scanner with a 160-row detector and rapid scanning. Incorporates FIRST iterative reconstruction to reduce exposure dose and enhance spatial resolution, and AiCE AI-based noise reduction using Deep Convolutional Neural Network methods to improve image quality in various anatomical regions.
Performance
Bench testing showed the device meets specifications for image quality metrics including contrast-to-noise ratio, CT number accuracy, spatial resolution, and noise power spectra. Clinical image evaluation confirmed diagnostic quality images for abdomen bone, brain CTA, and inner ear. Software and cybersecurity validations were also performed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/13/2022
2 months - 2
FDA Approval
3/7/2023
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