FDA AI Clearance Tracker/K253596
Radiology · 510(k)
Aquilion ONE (TSX-308A/TSX-306A) V2.0
Canon Medical Systems Corporation
- Device
- Aquilion ONE (TSX-308A/TSX-306A) V2.0
- Company
- Canon Medical Systems Corporation
- Submission number
- K253596
- Pathway
- 510(k)
- Decision date
- May 20, 2026
- Specialty (lead panel)
- Radiology
- Primary product code
- JAK
Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.