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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 the device name listed in this FDA 510(k) record. The listed applicant is Mevion Medical Systems. It received FDA 510(k) clearance on 2017-12-27 under 510(k) 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. The listed applicant is Mevion Medical Systems. The 510(k) number is K172848.

When did MEVION S250i Proton Beam Radiation Therapy Device receive FDA 510(k) clearance?

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

Who is the listed applicant for MEVION S250i Proton Beam Radiation Therapy Device?

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

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.

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 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.

K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)

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.K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion 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.

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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