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    Mevion Medical Systems, Inc.

    Manufacturer
    🇺🇸 United States·1 Basic UDI-DI·1 Device·BSI Group The Netherlands B.V.

    MEVION MEDICAL SYSTEMS, INC.

    FDA registration
    MEVION MEDICAL SYSTEMS, INC.·1 product·🇺🇸 United States

    Mevion S250i

    Device
    EU MDD · Eu Md Class 2b ·Mevion Medical Systems, Inc.·On the market·1 country

    Mevion Medical Systems

    FDA UDI
    MEVION MEDICAL SYSTEMS, INC.·00864366000100·Proton Beam Radiation Therapy System

    MEVION S250i

    FDA UDI
    MEVION MEDICAL SYSTEMS, INC.·00864366000124·

    Mevion S250i

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Mevion Medical Systems, Inc.·1 device

    MEVION S250I

    FDA Adverse Event
    Malfunction ·MEVION MEDICAL SYSTEMS, INC.·Product code LHN·November 4, 2020

    MEVION S250I

    FDA Adverse Event
    Malfunction ·MEVION MEDICAL SYSTEMS, INC.·Product code LHN·October 22, 2020

    MEVION S250I

    FDA Adverse Event
    Malfunction ·MEVION MEDICAL SYSTEMS, INC.·Product code LHN·May 22, 2024

    MEVION S250I

    FDA Adverse Event
    Malfunction ·MEVION MEDICAL SYSTEMS, INC.·Product code LHN·June 11, 2020

    MEVION S250I

    FDA Adverse Event
    Injury ·MEVION MEDICAL SYSTEMS, INC.·Product code LHN·February 1, 2024

    MEVION S250

    FDA Adverse Event
    Injury ·MEVION MEDICAL SYSTEMS, INC.·Product code LHN·January 13, 2017

    MEVION S250I PROTON THERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·MEVION MEDICAL SYSTEMS INC.·Product code LHN·January 15, 2025

    Mevion S250i

    Certificate
    MDD Annex II (excluding section 4)·Mevion Medical Systems, Inc.·BSI Group The Netherlands B.V.·1 Basic UDI-DI

    Regulatory Quality Management Information Source AREU, S.L.U

    Authorized representative
    🇪🇸 Spain·8 Manufacturers·51 Devices

    Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)

    FDA Recall
    Open, Classified ·Mevion Medical Systems, Inc.·Product code LHN·February 1, 2022

    MEVION S250, used for proton radiation therapy.

    FDA Recall
    Terminated ·Mevion Medical Systems, Inc.·Product code LHN·November 10, 2014

    MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.

    FDA Recall
    Terminated ·Mevion Medical Systems, Inc.·Product code LHN·June 29, 2018

    MEVION S250 Product Usage: Proton Radiation Therapy

    FDA Recall
    Terminated ·Mevion Medical Systems, Inc.·Product code MUJ·October 31, 2016

    MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy

    FDA Recall
    Terminated ·Mevion Medical Systems, Inc.·Product code LHN·March 5, 2014