Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems CorporationThe Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 is a 1.5 Tesla magnetic resonance imaging (MRI) system developed by Canon Medical Systems. It incorporates AI-based technologies in its reconstruction processing unit (AiCE) to improve image quality, reduce scan time, and assist operators. This system aids clinicians by producing high-resolution images of anatomical structures of the head and body, facilitating accurate diagnosis and efficient workflow.
Intended Use
Diagnostic imaging modality producing cross-sectional images of anatomical structures of the head or body, capable of non-contrast enhanced imaging such as MRA.
Technology
1.5 Tesla MRI system with AI-based AiCE reconstruction processing, including software updates for deep learning-driven motion correction, improved image encoding, and noise/artifact reduction techniques, supporting multiple imaging sequences and improved workflow features.
Performance
Performance testing included bench and clinical studies confirming improved image quality, artifact reduction, successful motion correction, and clinical usability. Testing with phantom and clinical images showed that AI reconstruction and motion correction met pre-defined acceptance criteria, and blinded radiologist reviews confirmed diagnostic quality and image enhancement.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/29/2024
2 months - 2
FDA Approval
4/12/2024
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