Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
Canon Medical Systems CorporationThe Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i is a whole-body multi-slice helical CT scanner enhanced with AiCE, an AI-based noise reduction algorithm using deep convolutional neural networks. It improves image quality and reduces noise for abdomen, pelvis, lung, cardiac, extremities, head, and inner ear scans, helping clinicians obtain clearer diagnostic images faster and with potentially reduced radiation dose.
Intended Use
Acquire and display cross sectional volumes of the whole body including the head for specialized studies using indicated software/hardware by trained physicians.
Technology
Whole body multi-slice helical CT scanner with gantry, couch, and console. AiCE is an AI noise reduction algorithm employing deep convolutional neural networks for enhanced image quality and noise reduction.
Performance
Bench and clinical testing showed equivalent or improved image quality compared to predicate devices. Metrics include contrast-to-noise ratio, CT number accuracy, uniformity, spatial resolution, low contrast detectability, and noise texture. Clinical images reviewed by radiologists confirmed diagnostic quality.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/19/2022
5 months - 2
FDA Approval
3/3/2023
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