Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems CorporationThe Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit is a 3 Tesla MRI system that produces detailed cross-sectional images of the head and body. It incorporates AI-powered image reconstruction (AiCE) and machine learning technologies to improve image quality, reduce artifacts, and assist in scan planning, helping clinicians obtain clearer and more precise diagnostic images efficiently.
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 system is a 3 Tesla MRI using the AiCE AI Reconstruction Processing Unit to improve image quality. It uses advanced artifact suppression techniques (mART EXP, RDC DWI), machine learning-based automatic scan planning for liver, prostate, and spine (LiverLine+, ProstateLine+, W-SpineLine+), iterative motion correction (IMC), and non-contrast perfusion imaging (pCASL).
Performance
Performance testing includes bench testing and volunteer imaging to confirm AI features such as liver, prostate, and spine plane detection, artifact reduction sequences, motion correction, distortion reduction, and perfusion imaging meet acceptance criteria. Safety and efficacy were supported by phantom and volunteer studies following recognized standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/24/2022
2 months - 2
FDA Approval
4/8/2022
Other devices from Canon Medical Systems Corporation
- Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)2024 • 510K
- 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
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.