K250986 is an FDA 510(k) clearance for the S250-FIT Proton Beam Radiation Therapy Device (S250-FIT). This device is classified as a System, Radiation Therapy, Charged-particle, Medical (Class II - Special Controls, product code LHN).
Submitted by Mevion Medical Systems, Inc. (Littleton, US). The FDA issued a Cleared decision on September 12, 2025, 165 days after receiving the submission on March 31, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K250986 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2025 |
| Decision Date | September 12, 2025 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LHN - System, Radiation Therapy, Charged-particle, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |