Radiology

Aquilion Precision (TSX-304A/4) V10.10 with AiCE

Canon Medical Systems Corporation

FDA-cleared AI medical device

FDA Submission Metadata

Submission number
K220986
Decision date
September 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.

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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.