Aquilion Precision (TSX-304A/4) V10.10 with AiCE
Canon Medical Systems CorporationThe Aquilion Precision (TSX-304A/4) V10.10 with AiCE is a whole-body CT scanner with ultra-high resolution that uses advanced AI deep convolutional neural networks to reduce image noise and enhance image quality, particularly for abdominal, pelvic, lung, and cardiac scans. It helps clinicians obtain clearer, more detailed images while potentially reducing radiation dose, thereby improving diagnostic confidence and patient care.
Intended Use
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Precision has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications. AiCE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, lung, and cardiac applications.
Technology
The device is an ultra-high resolution, whole body multi-slice helical CT scanner with a 160-row detector and advanced reconstruction technology AiCE, which employs Deep Convolutional Neural Networks for noise reduction and image quality enhancement, reconstructing images at 1024x1024 HR/SHR resolution. It supports helical, volume, and ECG/respiratory gated scans across multiple body regions including abdomen, pelvis, chest, cardiac, extremities, and head. The console integration allows for improved workflow compared to prior predicate devices.
Performance
Bench testing using phantoms demonstrated equivalency to predicate devices across multiple image quality metrics such as contrast-to-noise ratio, CT number accuracy, noise power spectra, and spatial resolution. Clinical image review by board-certified radiologists confirmed diagnostic quality of images. The device performed dose-neutral or improved low contrast detectability and high contrast spatial resolution compared to predicate using AiCE AI reconstruction methods.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/4/2022
5 months - 2
FDA Approval
9/12/2022
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