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510(k) Data Aggregation

    K Number
    K181676
    Device Name
    Mini Ridge Filter and auxiliary functions for PROBEAT-V
    Manufacturer
    Hitachi Ltd. Healthcare Hitachi Works
    Date Cleared
    2018-08-15

    (51 days)

    Product Code
    LHN
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hitachi Ltd. Healthcare Hitachi Works

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PROBEAT-V is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Device Description
    The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment. The beam delivery system is composed of the following components - Gantry Room o - . Rotating Gantry - Scanning Nozzle . - . Patient Positioning System - Cone Beam CT / X-ray Imaging System . - Fixed Beam Room o - . Scanning Nozzle - Patient Positioning System 트 - . Cone Beam CT / X-ray Imaging System The beam production system is composed of the following components - Accelerator system (LINAC, Synchrotron) o - O Beam transport system (Low/High Energy Beam Transport systems) The system incorporates several optional features and accessories, namely: - The Mini Ridge Filter ("mRF") is an optional accessory to modify the beam of the o PROBEAT-V system. The mRF is installed manually and may be used in conjunction with the range shifters inside the nozzle or extended range shifter. The mRF can be added to the cleared PROBEAT-V nozzle to spread out the Bragg peak along the axis of the beam in order to reduce the amount of beam energy in the delivery of proton radiation to defined target volumes. - Beam gating function allowing for interface with cleared external gating systems to o control the beam delivery for treatment such as to synchronize irradiation with respiration. Although the overall treatment time tends to be longer than the treatment time without gating, the extension of the treatment time will not affect irradiation performance to the target treatment site. Instead, the gating functionality may limit radiation exposure to regions outside of the target treatment volume. - Allows for use of fluoroscopy during proton irradiation at the physician's discretion. o Fluoroscopy may be used for observation of treatment site during treatment, which could be used for interruption of the treatment or analysis for treatment planning.
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