K232022
- 510(k) number
- K232022
- Device name
- CAS-One IR
- Applicant
- Cascination AG CH
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2024-03-13
- Date received
- 2023-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232022.pdf
Official FDA record: K232022
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.