K251645
- 510(k) number
- K251645
- Device name
- Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2025-09-26
- Date received
- 2025-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K251645.pdf
Official FDA record: K251645
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.