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FDA 510(k)

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)

K-Number: K253406 · 2026-03-25

ApplicantMevion Medical Systems, Inc.
Decision Date2026-03-25
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) is a medical device manufactured by Mevion Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-03-25 under approval number K253406. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)?

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) is a medical device that received FDA 510(k) clearance on 2026-03-25. It is manufactured by Mevion Medical Systems, Inc.. The 510(k) number is K253406.

When was S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) approved by the FDA?

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) received FDA 510(k) clearance on 2026-03-25, under approval number K253406.

What company makes S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)?

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) is manufactured by Mevion Medical Systems, Inc..

What is the FDA product code for S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)?

The FDA product code for S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) is LHN.

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Related PubMed Literature

PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (2026) PMID: 41072144 Use of Bayesian decision analysis in the design of patient-centered clinical trials for kidney failure devices. Computers in biology and medicine (2025) PMID: 41052472 Successful management of recurrent multiple intracerebral TFE3-rearranged epithelioid hemangioendothelioma with repeated intervention and active surveillance: illustrative case. Journal of neurosurgery. Case lessons (2025) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025)

Other Devices by Mevion Medical Systems, Inc.

K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)

Related Devices (Code: LHN)

K162246ProNova SC360 Proton Therapy SystemPronova Solutions, LLC K160612Sumitomo Proton Therapy SystemSumitomo Heavy Industries, Ltd. K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A. K161163PROBEAT-V Proton Beam Therapy System with X-ray Limiting AccessoryHitachi , Ltd. K160432Anzai Respiratory Gating SystemAnzai Medical Co., Ltd. K153614PROBEAT-V and accessoriesHitachi, Ltd., Health Care Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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