Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I
Canon Medical Systems CorporationThe Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-i is a whole-body multi-slice helical CT scanner that acquires and displays cross-sectional volume images, including the head. It incorporates AiCE, an AI-based noise reduction algorithm using deep convolutional neural networks, to improve image quality and reduce noise in scans of the abdomen, pelvis, lung, extremities, head, and inner ear. This technology helps clinicians obtain clearer images at potentially lower radiation doses, facilitating better diagnostic accuracy.
Intended Use
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Exceed LB 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. 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, extremities, head and inner ear applications.
Technology
The Aquilion Exceed LB is a multi-slice helical CT scanner consisting of a gantry, couch, and a console for data processing and display. It incorporates AiCE-i, an advanced noise reduction algorithm that utilizes Deep Convolutional Neural Network methods to reduce image noise and improve image quality during reconstruction. The AiCE algorithm differentiates signal from noise allowing for fast, high-quality CT reconstructions. The system leverages PURE ViSION detectors and supports extended field-of-view and respiratory-gating. AiCE is applied to abdomen, pelvis, lung, extremities, head, and inner ear applications.
Performance
Bench testing with phantoms was conducted to assess image quality metrics including contrast-to-noise ratio, CT number accuracy, uniformity, slice sensitivity profile, modulation transfer function, and noise power spectra. Results demonstrated substantially equivalent or improved performance relative to the predicate device. Phantom studies showed dose reduction up to 82% with AiCE abdomen protocol compared to filtered back projection. Noise texture and spatial resolution studies supported claims of improved image quality and noise reduction. Clinical images were deemed not necessary for substantial equivalence evidence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/6/2020
2 months - 2
FDA Approval
12/10/2020
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