Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems CorporationThe Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR is a 3 Tesla MRI system produced by Canon Medical Systems Corporation. It provides high-quality cross-sectional images of anatomical structures in the head or body, including advanced imaging techniques such as non-contrast enhanced MRA and diffusion imaging. The AiCE Reconstruction Processing Unit uses AI to enhance and speed up the image reconstruction process, helping clinicians obtain clear and detailed MR images for diagnosis.
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 Vantage Galan MRT-3020 is a 3 Tesla MRI system that uses a new in-house magnet and gradient coil, a new Real-time Platform architecture for stable and high-speed processing by the Real Time Manager. It includes advanced software applications such as AI-supported 4D Flow visualization for blood flow analysis, Zoom DWI for smaller field-of-view diffusion imaging to reduce artifacts, and 3D-QALAS for quantitative T1, T2, and PD mapping using an interleaved Look-Locker sequence with T2 prep and IR pulses. The AiCE Reconstruction Processing Unit utilizes AI methods to improve MRI image reconstruction.
Performance
Performance testing included bench tests and volunteer imaging for the 4D Flow, Zoom DWI, and 3D-QALAS sequences. Clinical image quality was evaluated by expert reviewers comparing contrast and signal strength against published reference images. Risk management and software verification/validation were conducted following FDA guidance. Testing demonstrated the device meets predetermined acceptance criteria and is safe and effective for its intended use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/28/2024
2 months - 2
FDA Approval
8/20/2024
Other devices from Canon Medical Systems Corporation
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.