S250-FIT Proton Beam Radiation Therapy Device
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250986 FDA 510(k)
- FDA Product Code
- LHN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The S250-FIT is a Charged-Particle Radiation Therapy System designed to deliver proton beam therapy for the treatment of localized tumors and other targeted radiation indications. As a compact, self-shielded proton accelerator, it utilizes a gantry-mounted system to provide precise, high-energy proton beams with uniform stability, enabling conformal dose delivery to tumor sites while minimizing exposure to surrounding healthy tissue.
This device is intended for use in radiation oncology facilities and is supplied as a reusable, non-sterile medical system. It operates under FDA 510(k) clearance (K250986) and adheres to the Medical Device Directive (MDD) for regulatory compliance. The system is engineered to fit within existing linear accelerator vaults, offering flexibility for integration into existing infrastructure. No MRI safety classifications or single-use components are specified in the regulatory data.
Frequently asked questions
What types of medical facilities are the S250-FIT designed to integrate into, and why is this important for potential buyers?
The S250-FIT is engineered to fit within existing linear accelerator vaults, making it ideal for radiation oncology facilities that already have infrastructure in place. This compact, self-shielded design allows for easier integration without requiring major renovations, reducing installation costs and downtime for buyers.
How is the S250-FIT supplied, and what does this mean for maintenance and operational workflows?
The S250-FIT is supplied as a reusable, non-sterile medical system. This means it is designed for repeated use within a facility, requiring proper cleaning and maintenance protocols to ensure safety and performance. Clinicians and staff should follow manufacturer guidelines for upkeep, as it is not intended for single-use.
What regulatory pathways does the S250-FIT follow, and how does this affect its use in different markets?
The S250-FIT is cleared under the FDA’s 510(k) pathway (K250986) and complies with the Medical Device Directive (MDD). This indicates it has undergone evaluation for safety and effectiveness in the U.S. and aligns with European regulatory standards, though buyers should verify local compliance requirements for their specific region.
Does the S250-FIT have any special considerations for MRI compatibility, and why might this matter for a facility?
The S250-FIT does not specify any MRI safety classifications in its regulatory data. For facilities combining proton therapy with MRI-guided treatments, this lack of classification means additional safety protocols may be required to ensure compatibility, as the device’s electromagnetic properties or shielding could interact with MRI systems.
What clinical specialties would most benefit from the S250-FIT, and why is proton beam therapy preferred in certain cases?
The S250-FIT is classified under the medical specialty of Radiology, specifically for radiation oncology. Proton beam therapy is particularly advantageous for treating localized tumors, as it delivers precise, high-energy proton beams that conform closely to the tumor site while sparing surrounding healthy tissue. This makes it ideal for complex cases like pediatric cancers, brain tumors, or tumors near critical organs where minimizing radiation exposure is critical.
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 S250 Proton Therapy System, S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (K250986 ..., Mevion S250-FIT - Leo Cancer Care
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K250986 | Class II | Active |
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Manufacturer
- Manufacturer
- Mevion Medical Systems, Inc.
Sources (2)
- FDA 510(k) K250986 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026