Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Mevion Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-03-25 under 510(k) 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. The listed applicant is Mevion Medical Systems, Inc.. The 510(k) number is K253406.

When did S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) receive FDA 510(k) clearance?

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

Who is the listed applicant for S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)?

The FDA 510(k) record lists Mevion Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT01857934Therapy for Children With Advanced Stage NeuroblastomaCOMPLETEDNCT04968990Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam IrradiationRECRUITINGNCT06465966UFPTI 2403-PR12: Real-Time Volumetric Ionizing Radiation Acoustic Imaging for In-vivo Proton Treatment Monitoring in Pencil-Beam ScanningRECRUITING

Other records listing Mevion Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)K172848MEVION S250i Proton Beam Radiation Therapy Device

Related Devices (Code: LHN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K243900eMotus Respiratory Motion Management SystemEmpnia, Inc.K242418P-Cure Proton Therapy System (PPTS)P-Cure, Ltd.K232032PROBEAT-FRHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

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.

↑