- All Devices
- Radiology
- Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR
Radiology
Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
FDA-cleared AI medical device
FDA Submission Metadata
- Submission number
- K240238
- Decision date
- April 2024
- FDA panel
- Radiology
- Product code
- LNH
- Clinical task (npj)
- acquisition guidance|image enhancement
- Data modality (npj)
- Images
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.