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510(k) Data Aggregation

    K Number
    K250986
    Date Cleared
    2025-09-12

    (165 days)

    Product Code
    Regulation Number
    892.5050
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K221996

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MEVION S250-FIT Proton Beam Radiation Therapy Device is intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation. When the patient is in the fully seated position, the MEVION S250-FIT is indicated for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation in the sites above the mid-chest or carina.

    Device Description

    The MEVION S250-FIT Proton Beam Radiation Therapy Device is a proton beam radiation therapy system that provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose and three-dimensional dose distribution to the prescribed patient treatment site. The MEVION S250-FIT delivers radiation via a pencil beam (spot) scanning modality. In order to reach a target depth of 32cm in the patient, the accelerator is designed to produce a 230MeV beam.

    The S250-FIT is comprised of 6 subsystems:

    • Beam Generation System – generates the beam and directs it to the beam delivery system.
    • Beam Delivery System – ensures that the therapeutic prescription parameters are properly delivered.
    • Hardwired Safety System (HSS) – provides for system and beam delivery interlocking without the use of software
    • Patient Positioning System – The Marie Device from Leo Cancer Care (K250970) allows for accurate and efficient positioning of the patient in a seated or perched position for treatment using an Upright Patient Positioner and 3D CT Scanner for Treatment Planning and Patient Registration.
    • Structural Support/Alignment System – supports the beam generation and delivery systems and allows the fixed beam delivery to the single point in space (i.e., the Isocenter)
    • System Software – controls the above subsystems (except the HSS) and provides interfaces to the system for the end-user.
    AI/ML Overview

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