K253596
- 510(k) number
- K253596
- Device name
- Aquilion ONE (TSX-308A/TSX-306A) V2.0
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2026-05-20
- Date received
- 2025-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253596.pdf
Official FDA record: K253596
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.