K232835
- 510(k) number
- K232835
- Device name
- Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2024-04-02
- Date received
- 2023-09-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232835.pdf
Official FDA record: K232835
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.