Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

510k7/14/2020

FDA #

K193097

Product Code

LNH

Panel

Radiology

Modality:MRI Task:Reconstruction Body Region:Neurological

The Vantage Orian 1.5T with AiCE Reconstruction Processing Unit for MR is a 1.5 Tesla MRI system from Canon that enhances image quality by using AI-powered noise reduction techniques. This advanced software algorithm uses deep learning to reduce thermal noise and improve signal clarity, especially in brain and knee imaging, helping clinicians obtain clearer and more diagnostically useful MRI images.

Intended Use

Vantage Orian 1.5T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA. MRI images correspond to the spatial distribution of protons (hydrogen nuclei) with properties useful in diagnosis.

Technology

AiCE is an optional noise reduction algorithm that improves image quality and reduces thermal noise by employing deep convolutional neural network methods. The device removes Gaussian distributed noise from MR images by training on high-SNR images with added Gaussian noise, enhancing image clarity particularly for brain and knee regions.

Performance

Performance testing for AiCE included bench testing with a model observer study and a human observer study with 6 board certified radiologists over 160 image datasets. Results showed AiCE improved or maintained low contrast detectability and was statistically preferred compared to other filters. SNR measurements confirmed increased signal-to-noise ratio and maintained contrast in brain and knee images.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

1
Submission
11/7/2019
8 months
2
FDA Approval
7/14/2020

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