K250970
- 510(k) number
- K250970
- Device name
- Marie
- Applicant
- Leo Cancer Care WI · US
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2025-07-25
- Date received
- 2025-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K250970.pdf
Official FDA record: K250970
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.