K250970 is an FDA 510(k) clearance for the Marie. This device is classified as a System, X-ray, Tomography, Computed (Class II - Special Controls, product code JAK).
Submitted by Leo Cancer Care (Middleton, US). The FDA issued a Cleared decision on July 25, 2025, 116 days after receiving the submission on March 31, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750.
| 510(k) Number | K250970 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2025 |
| Decision Date | July 25, 2025 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAK — System, X-ray, Tomography, Computed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1750 |