Radiology
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
Canon Medical Systems Corporation
FDA-cleared AI medical device
FDA Submission Metadata
- Submission number
- K192832
- Decision date
- February 2020
- FDA panel
- Radiology
- Product code
- JAK
- Clinical task (npj)
- 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.