Vantage Orian 1.5T, MRT-1550, V6.0
Canon Medical Systems CorporationThe Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit is a 1.5 Tesla MRI system from Canon Medical Systems designed to produce detailed cross-sectional images of the head or body for diagnostic use. It includes AI-based image reconstruction technology (AiCE) that enhances image quality and processing for a variety of anatomical regions, helping clinicians make more accurate diagnoses.
Intended Use
Vantage Orian 1.5T 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. This system is capable of non-contrast enhanced imaging, such as MRA. MRI images correspond to spatial distribution of protons exhibiting nuclear magnetic resonance. Depending on region, contrast agents may be used. Interpreted by a trained physician, these images yield information useful in diagnosis.
Technology
The Vantage Orian 1.5T is a 1.5 Tesla MRI system utilizing a 1.4 m short and 3.8 tons lightweight magnet with Pianissimo noise reduction technology. It has gradient and WB coil design providing up to 55x55x50 cm FOV. The AiCE Reconstruction Processing Unit applies AI deep learning for enhanced MR image reconstruction across multiple anatomical regions.
Performance
Performance was evaluated with bench testing using a model observer study and human observer study with certified radiologists and 55 studies. Testing showed that AiCE performs equal to or better than commercially available predicate devices. Safety and imaging parameters remain unchanged compared to predicate systems, with compliance to IEC standards and ISO 13485 quality system standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/21/2020
3 months - 2
FDA Approval
1/15/2021
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- Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR2024 • 510K
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