Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
Canon Medical Systems CorporationThe Aquilion Prime SP V10.2 with AiCE-i is an advanced CT imaging system that uses artificial intelligence through Deep Convolutional Neural Networks to reduce image noise and improve image clarity. This system helps clinicians capture better quality whole-body CT scans, including the head, optimizing image quality and potentially reducing radiation dose for patients.
Intended Use
Indicated to acquire and display cross-sectional volumes of the whole body including the head; provides volume datasets for specialized studies by qualified physicians. AiCE is an AI noise reduction algorithm that enhances image quality using Deep Convolutional Neural Networks for abdomen, pelvis, lung, cardiac, extremities, head, and inner ear applications.
Technology
A 40-row CT system optionally upgradeable to 80 detector rows; uses AiCE-i, an AI-based noise reduction algorithm employing Deep Convolutional Neural Networks for improved image quality and lower noise compared to previous reconstruction techniques like AIDR 3D and FBP.
Performance
Performance testing includes phantom-based image quality evaluations assessing contrast-to-noise ratio, low contrast detectability, and noise texture analyses. Results demonstrate an 82% dose reduction claim relative to FBP, 13.8% improved low contrast detectability, and significantly better noise reduction compared to previous methods. Clinical images confirmed diagnostic quality.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/2/2019
4 months - 2
FDA Approval
2/21/2020
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