Data / Medical devices / United States / Mevion Medical Systems, Inc.
Mevion Medical Systems, Inc.: FDA-registered device maker in Littleton, MA, United States, 4 510(k) clearances
Mevion Medical Systems, Inc. is registered with the FDA (registration 3007087027) in Littleton, MA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated March 25, 2026. 14 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3007087027
- Address
- 300 Foster St, Littleton, MA, United States, 01460
- Owner or operator
- Mevion Medical Systems, Inc. (10041144)
- Roles
- Manufacturer
- First device listed
- June 25, 2012
- Registered through
- 2026
- Brand names listed
- FIT PROTON THERAPY IN YOUR LINAC VAULT, MEVION S250 Proton Therapy System, MEVION S250i Proton Therapy System / MEVION S250mx Multi-Room Proton Therapy System, Mevion S250-FIT Proton Therapy System / S250-FIT / FIT, S250-FIT Proton Beam Radiation Therapy Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Radiation Therapy, Charged-Particle, Medical | LHN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 25, 2026 | K253406 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | LHN | Substantially Equivalent | Mevion Medical Systems, Inc. | accessdata.fda.gov |
| September 12, 2025 | K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | LHN | Substantially Equivalent | Mevion Medical Systems, Inc. | accessdata.fda.gov |
| December 27, 2017 | K172848 | MEVION S250i Proton Beam Radiation Therapy Device | LHN | Substantially Equivalent | Mevion Medical Systems | accessdata.fda.gov |
| June 4, 2012 | K120676 | S-250 PROTON BEAM RADIATION THERAPY SYSTEM | LHN | Substantially Equivalent | Mevion Medical Systems | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 1, 2022 | 89758 | Class II | Ongoing | Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) | Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room. | accessdata.fda.gov |
| October 19, 2020 | 86693 | Class II | Terminated | MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation | Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur | accessdata.fda.gov |
| June 23, 2020 | 86028 | Class II | Terminated | MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients | The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer. | accessdata.fda.gov |
| May 15, 2020 | 85748 | Class II | Terminated | MEVION S250i, MEVION S250; Proton Radiation Treatment System | Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off | accessdata.fda.gov |
| October 1, 2018 | 81751 | Class II | Terminated | MEVION S250i | Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped | accessdata.fda.gov |
| June 29, 2018 | 80615 | Class II | Terminated | MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by rad | QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged when used with incompatible (third-party) accessories. This can create unsafe conditions for use and may compromise the subse | accessdata.fda.gov |
| December 16, 2016 | 76090 | Class II | Terminated | MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy | An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened | accessdata.fda.gov |
| October 31, 2016 | 75496 | Class II | Terminated | MEVION S250 Product Usage: Proton Radiation Therapy | Completing Setup Without Program Move Complete Can Cause An Isocenter Error | accessdata.fda.gov |
| October 21, 2016 | 75498 | Class II | Terminated | MEVION S250 Product Usage: Proton Radiation Therapy System | Recovery of Incorrect Isocenter -operational change | accessdata.fda.gov |
| October 20, 2016 | 75494 | Class II | Terminated | MEVION S250 Product Usage: Proton Radiation Therapy System | Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter | accessdata.fda.gov |
| March 15, 2016 | 73602 | Class II | Terminated | MEVION S250 for Proton Radiation Therapy | Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury or death. | accessdata.fda.gov |
| November 18, 2015 | 72210 | Class II | Terminated | MEVION S250 Radiation therapy system | The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment. | accessdata.fda.gov |
| November 10, 2014 | 69778 | Class II | Terminated | MEVION S250, used for proton radiation therapy. | Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%. | accessdata.fda.gov |
| March 5, 2014 | 67657 | Class II | Terminated | MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy | Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields | accessdata.fda.gov |
Compare with other makers
Updated March 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.