Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems CorporationThe Vantage Galan 3T with AiCE Reconstruction Processing Unit is a 3 Tesla MRI system from Canon that uses deep convolutional neural networks to reduce thermal noise and improve image quality in MRI scans, particularly for brain and knee regions. This advanced software and hardware combination helps clinicians obtain clearer MRI images, enhancing diagnosis without increasing scan time or contrast use.
Intended Use
Vantage Galan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body capable of non-contrast enhanced imaging, such as MRA.
Technology
AiCE is an optional noise reduction algorithm employing Deep Convolutional Neural Network methods to reduce Gaussian thermal noise in MRI images. Training datasets were generated by adding Gaussian noise to high-SNR images. The software operates with the AiCE Reconstruction Processing Unit hardware and is compatible with Canon MRI systems.
Performance
Performance testing included bench testing with a Model Observer study confirming maintained or improved low contrast detectability, and a Human Observer study with 6 physicians and 160 images showing a statistical preference for AiCE over other filters. Testing demonstrated that AiCE performed at or above predicate device levels.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/19/2019
5 months - 2
FDA Approval
3/9/2020
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- Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR2024 • 510K
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