Radiology
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A
Canon Medical Systems Corporation
FDA-cleared AI medical device
FDA Submission Metadata
- Submission number
- K213504
- Decision date
- June 2022
- FDA panel
- Radiology
- Product code
- JAK
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.