Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
Canon Medical Systems CorporationThe Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System is a whole-body CT scanner that can capture detailed cross-sectional volume images of organs in a single rotation. It uses advanced AI algorithms such as deep convolutional neural networks to improve image quality and reduce noise, helping clinicians to better visualize anatomy and potentially optimize iodinated contrast media use. The spectral imaging system acquires images at different energy levels nearly simultaneously to differentiate tissues and materials, assisting in diagnosis and treatment planning.
Intended Use
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include, but are not limited to brain, heart, pancreas, etc. The Aquilion ONE has the capability to provide volume sets of the entire organ, used by a trained and qualified physician to perform specialized studies.
Technology
This system is a multi-slice helical CT scanner consisting of a gantry, couch, and a data console. It uses rapid kV switching spectral imaging to acquire two simultaneous CT images at different energy levels. It incorporates an iterative reconstruction algorithm (FIRST) to reduce dose and improve spatial resolution and an AI-based noise reduction algorithm (AiCE) employing deep convolutional neural networks to enhance image quality for multiple body regions.
Performance
Bench testing using phantoms demonstrated that spectral images have comparable or improved contrast-to-noise ratios, uniformity, and low contrast detectability compared to the predicate device. Noise reduction studies showed a 50% noise reduction relative to single energy imaging, and iodine concentration reduction studies indicated potential for decreased contrast media use. Clinical image reviews by a board-certified radiologist confirmed the diagnostic quality of spectral images. Software and cybersecurity validations were performed according to FDA guidance and IEC standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/2/2020
4 months - 2
FDA Approval
3/24/2021
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