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 designed to produce detailed cross-sectional images of the head or body. It incorporates AI-based deep learning technology, called the Precise IQ Engine (PIQE), which enhances image resolution, reduces artifacts, and maintains or improves image quality. This helps clinicians obtain clearer and more precise images for diagnosis without additional scan time or parameters adjustment.
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 incorporating a the AI-based Precise IQ Engine (PIQE), a deep learning based image reconstruction technique that enhances in-plane image resolution from low matrix images while mitigating ringing artifacts. PIQE has been extended to support multiple scan families, weightings, and anatomical areas. The system includes hardware components such as a standard gradient system and amplifier, compatible with previous versions, and software updates that incorporate PIQE as a post-processing algorithm to improve image sharpness, signal-to-noise ratio, and artifact reduction.
Performance
Performance testing included bench testing and a multi-site, randomized, blinded clinical image review study with 14 board-certified radiologists and cardiologists. Clinical testing demonstrated that the AI-based reconstruction provides higher spatial resolution images with reduced noise and artifacts compared to conventional methods, and maintains clinically acceptable image quality across multiple anatomical regions including body, breast, cardiac, musculoskeletal, and neuro. Software validation, risk management, and cybersecurity documentation were also completed per FDA guidance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/24/2024
2 months - 2
FDA Approval
1/7/2025
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.