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FDA 510(k)

MEVION S250i Proton Beam Radiation Therapy Device

K-Number: K172848 · 2017-12-27

ApplicantMevion Medical Systems
Decision Date2017-12-27
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEVION S250i Proton Beam Radiation Therapy Device is a medical device manufactured by Mevion Medical Systems. It received FDA 510(k) clearance on 2017-12-27 under approval number K172848. 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 MEVION S250i Proton Beam Radiation Therapy Device?

MEVION S250i Proton Beam Radiation Therapy Device is a medical device that received FDA 510(k) clearance on 2017-12-27. It is manufactured by Mevion Medical Systems. The 510(k) number is K172848.

When was MEVION S250i Proton Beam Radiation Therapy Device approved by the FDA?

MEVION S250i Proton Beam Radiation Therapy Device received FDA 510(k) clearance on 2017-12-27, under approval number K172848.

What company makes MEVION S250i Proton Beam Radiation Therapy Device?

MEVION S250i Proton Beam Radiation Therapy Device is manufactured by Mevion Medical Systems.

What is the FDA product code for MEVION S250i Proton Beam Radiation Therapy Device?

The FDA product code for MEVION S250i Proton Beam Radiation Therapy Device 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)

Related Devices (Code: LHN)

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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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