Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems CorporationThe Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR is a 3 Tesla MRI system developed by Canon Medical Systems Corporation. It produces detailed cross-sectional images of the body and head using advanced AI-powered reconstruction techniques to enhance image quality, reduce artifacts, and improve workflow for clinicians. The device supports various deep learning-based features for motion correction, image resolution enhancement, noise reduction, and automated scan protocols, aiding diagnosis and patient care.
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 that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
Technology
The device is a 3 Tesla MRI system with modifications including software updates that use deep learning methods for motion correction (Iterative Motion Correction), dynamic contrast-enhanced imaging (Free Breathing Dynamic), artifact reduction, image denoising (DSD filter), and improved image resolution (Precise IQ Engine). It includes an AiCE Reconstruction Processing Unit and features to automate exam protocols and image alignment (Auto Protocol Brain Application, NeuroLine+). High-speed data transfer is supported with a 10GbE reconstruction kit.
Performance
Extensive bench and clinical testing was performed including phantom and clinical image evaluations. Testing validated improvements in image quality, reduction in artifacts, denoising, image sharpness, motion correction effectiveness, and success in automated positioning and phase detection. Clinical image reviews by multiple board-certified radiologists confirmed that images processed with AI techniques maintain or improve diagnostic quality and are clinically acceptable.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/9/2023
6 months - 2
FDA Approval
8/30/2023
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- Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR2024 • 510K
- Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR2024 • 510K
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