K231748
- 510(k) number
- K231748
- Device name
- Cartesion Prime (PCD-1000A/3) V10.15
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2023-09-12
- Date received
- 2023-06-15
- 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: K231748.pdf
Official FDA record: K231748
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.