Aquilion Serve SP (TSX-307B/1) V1.3
Canon Medical Systems CorporationThe Aquilion Serve SP (TSX-307B/1) V1.3 is a multi-slice helical CT scanner that acquires and displays whole-body cross-sectional imaging volumes. It includes an AI-based noise reduction algorithm called AiCE (Advanced Intelligent Clear-IQ Engine) that enhances image quality by reducing noise using deep learning techniques. This helps clinicians obtain clearer diagnostic images for various applications including abdomen, pelvis, lung, cardiac, extremities, head, and inner ear imaging.
Intended Use
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion Serve SP 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, cardiac, extremities, head and inner ear applications.
Technology
The device is a whole-body multi-slice helical CT scanner consisting of a gantry, couch, and console for data processing and display. It includes AI-based noise reduction using deep convolutional neural networks called AiCE for multiple body regions. It utilizes a SilverBeam Filter to optimize the X-ray spectrum by removing low energy photons, thus improving CT image quality. The system features a 7.5 MHU X-ray tube with increased generator output and is based on proven Canon CT technologies.
Performance
Bench testing included assessment of image quality metrics such as contrast-to-noise ratio, CT number accuracy, uniformity, modulation transfer function, noise power spectra, and low contrast detectability using phantoms. Dose reduction was validated using SilverBeam Filter and dose reduction mode against normal scan modes showing effective radiation dose reduction in head and body scans. Software verification and validation were performed to meet FDA guidance, and the device complies with multiple relevant IEC and FDA radiation safety standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/29/2023
2 months - 2
FDA Approval
12/6/2023
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