K231281
- 510(k) number
- K231281
- Device name
- Aquilion Serve (TSX-307A/1) V1.3
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2023-09-19
- Date received
- 2023-05-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K231281.pdf
Official FDA record: K231281
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.