K242403
- 510(k) number
- K242403
- Device name
- Aquilion ONE (TSX-308A/3) V1.5
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2024-12-23
- Date received
- 2024-08-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K242403.pdf
Official FDA record: K242403
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.