K233334
- 510(k) number
- K233334
- Device name
- Aquilion Serve SP (TSX-307B/1) V1.3
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2023-12-06
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K233334.pdf
Official FDA record: K233334
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.