K243398
- 510(k) number
- K243398
- Device name
- CT Scanner TSX-501R/1 V11.1
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2025-06-20
- Date received
- 2024-10-31
- 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: K243398.pdf
Official FDA record: K243398
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.