Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System

Canon Medical Systems Corporation

510k2/13/2020

FDA #

K192828

Product Code

JAK

Panel

Radiology

Modality:CT Task:Reconstruction Body Region:Whole Body

The Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System is a whole-body multi-slice helical CT scanner. It captures high-quality cross-sectional volume images of whole organs in a single rotation. It includes advanced AI algorithms—AiCE for noise reduction using Deep Convolutional Neural Networks and FIRST iterative reconstruction to improve image quality and reduce radiation dose. It supports spectral imaging with rapid kV switching to differentiate material composition in tissues, aiding clinicians in diagnosis and treatment planning.

Intended Use

Indicated to acquire and display cross-sectional volumes of the whole body, including head, with capability to image whole organs in a single rotation; specialized studies by qualified physicians.

Technology

Whole body multislice helical CT scanner using rapid kV switching for spectral imaging; employs AiCE deep neural network noise reduction and FIRST iterative reconstruction to improve image quality and reduce dose.

Performance

Bench and clinical testing show diagnostic quality images with significant noise reduction (up to 32%) and dose reduction (69-81%) compared to prior algorithms; spectral imaging demonstrated equivalent image quality and additional artifact reduction; clinical images reviewed by board-certified radiologists confirmed diagnostic suitability.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

1
Submission
10/2/2019
4 months
2
FDA Approval
2/13/2020

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