Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems CorporationThe Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR is an advanced 3 Tesla MRI system by Canon Medical Systems. It utilizes AI-based deep learning reconstruction to improve image quality across various anatomical regions. This helps clinicians by providing clearer, high-quality diagnostic images of the head, body, and multiple specific anatomical areas, improving diagnostic confidence without changing the existing hardware or basic MRI functions.
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 the AiCE Reconstruction Processing Unit for MR, which uses a deep learning model based approach to reconstruct MRI images with improved image quality. It is based on previously cleared Canon MRI technology, with no changes to software or hardware compared to the predicate device, and supports imaging for multiple anatomical regions.
Performance
Performance testing included bench testing of image low contrast detectability, SNR, and contrast performance using model observer studies, along with a human observer study involving 15 board certified radiologists/cardiologists and 60 subjects with 348 scans. Testing showed AiCE performed at the same or better level than predicate devices, maintaining or improving image quality.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/12/2020
3 months - 2
FDA Approval
3/4/2021
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