S250-FIT Proton Beam Radiation Therapy Device
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- MEVION S250i EUDAMEDFDA UDIMEVION S250-FIT Proton Therapy System EUDAMED
- Generic Name
- Proton therapy system FDA UDI
- Device Name
- MEVION S250-FIT Proton Therapy System EUDAMEDMevion S250i EUDAMED
- Model / Reference
- S250i EUDAMEDFDA UDIS250-FIT EUDAMED
Identifiers
- Catalog Number
- MEVION S250i FDA UDI
- Primary DI / UDI-DI
- 00864366000124 EUDAMEDFDA UDI00864366000117 EUDAMED
- Basic UDI-DI
- 08643660001S250L2 EUDAMEDB-00864366000124 EUDAMED
- Direct Marketing DI
- 00864366000117 EUDAMED
- FDA Product Code
- LHN FDA 510(k)FDA UDI
- EMDN Code
- Z11011001 PROTON THERAPY SYSTEMS EUDAMED
- GMDN Term
- Proton therapy system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)FDA UDI
- Market of Registration
- Italy EUDAMEDNetherlands EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The S250-FIT is a Proton Beam Radiation Therapy Device, designed to deliver precise proton therapy for cancer treatment. It employs a compact, self-shielded superconducting proton accelerator to generate high-energy proton beams, enabling targeted radiation delivery with reduced exposure to surrounding healthy tissue compared to conventional photon-based radiotherapy.
This device is intended for use in clinical radiation oncology settings and is supplied as a reusable medical system. It is classified under FDA Device Class II and adheres to Medical Device Directive (MDD) and Medical Device Regulation (MDR) standards. The S250-FIT is engineered to fit within existing linear accelerator (LINAC) vaults, ensuring compatibility with existing infrastructure. Authorized under FDA 510(k) clearance (K253406), it is regulated under FDA regulation number 892.5050 for radiation therapy systems.
Frequently asked questions
What types of cancer treatments can the S250-FIT Proton Beam Radiation Therapy Device be used for?
The S250-FIT is designed for proton beam radiation therapy, which is used to precisely target cancerous tumors while minimizing exposure to surrounding healthy tissue. This technology is particularly advantageous for treating complex cancers, such as those in the brain, prostate, lung, and pediatric tumors, where sparing healthy tissue is critical. Its compact, self-shielded accelerator allows for tailored radiation delivery in clinical radiation oncology settings.
Is the S250-FIT Proton Beam Radiation Therapy Device single-use or reusable, and what does that mean for maintenance?
The S250-FIT is supplied as a reusable medical system, meaning it is built to be used repeatedly in clinical settings. This design implies that maintenance, calibration, and servicing are required to ensure consistent performance and safety. Hospitals or facilities using this device will need to follow manufacturer guidelines for upkeep, including regular inspections and potential upgrades to components like the superconducting accelerator and beam delivery systems.
How does the S250-FIT fit into existing hospital infrastructure, particularly in terms of space requirements?
The S250-FIT is engineered to fit within existing linear accelerator (LINAC) vaults, making it a practical upgrade or addition for facilities already equipped with radiation therapy infrastructure. This compatibility reduces the need for extensive renovations or additional space, allowing hospitals to integrate proton therapy without major logistical disruptions. The compact, self-shielded design further optimizes space utilization.
What regulatory pathways does the S250-FIT follow, and how does that affect its use in different regions?
The S250-FIT is authorized under FDA 510(k) clearance (K253406) in the U.S., adhering to FDA regulation number 892.5050 for radiation therapy systems. Internationally, it complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) standards in Europe. These pathways ensure the device meets stringent safety and performance requirements in its respective markets, allowing clinicians to rely on its precision and reliability for proton therapy treatments.
What are the key advantages of using proton beam therapy with the S250-FIT compared to traditional photon-based radiotherapy?
The S250-FIT delivers proton beams, which offer superior precision compared to photon-based radiotherapy by depositing radiation energy more selectively within the tumor while sparing adjacent healthy tissue. This reduces side effects and complications, particularly for sensitive areas like the brain, spinal cord, or pediatric patients. The compact, self-shielded design also enhances safety for staff and patients by minimizing radiation leakage, making it a more advanced and controlled treatment option.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: mevion-s250-fit-proton-therapy-system – Mevion Medical Systems | Proton Therapy, MEVION S250-FIT: Proton Therapy That FITs ... - Leo Cancer Care, Mevion S250 Proton Therapy System – Mevion Medical Systems | Proton Therapy
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K253406 | Class II | Active |
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Manufacturer
- Manufacturer
- Mevion Medical Systems, Inc.
Sources (4)
- FDA 510(k) K253406 24 fields · synced Oct 6, 2026
- FDA UDI f5ca1d4e-e4ec-462c-bfeb-172b0bd47675 35 fields · synced May 30, 2026
- EUDAMED f5622732-6bbc-4d6e-8398-122be00f3c9c 61 fields · synced Jul 9, 2026
- EUDAMED 451f7a0e-1e80-4bc9-862f-66dbd7c6f4f0 61 fields · synced Sep 17, 2026