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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: LHN FDA class 2

    System, Radiation Therapy, Charged-Particle, Medical

    Radiology

    View full classification →

    A charged-particle medical radiation therapy system is a radiotherapy device that uses beams of charged particles such as protons or carbon ions to deliver targeted radiation doses to tumors, allowing more precise dose deposition and reduced exposure to surrounding healthy tissue compared to conventional photon-based radiotherapy. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LHN and is regulated under 21 CFR 892.5050 within the Radiology specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    eMotus Respiratory Motion Management System
    P-Cure Proton Therapy System (PPTS)
    PROBEAT-FR
    ProBeam 360° Proton Therapy System v2.0 (Multiroom)
    P-Cure Proton Beam Therapy System
    Small Field Applicator
    ProBeam 360° Proton Therapy System
    myQA iON
    PROBEAT-CR
    Orfit Aerial Couchtop
    Blue Phantom PT
    Radiance 330 Proton Beam Therapy System
    PROBEAT-CR
    X-ray Imaging System for the McLaren Proton Treatment System
    VeriSuite
    Mini Ridge Filter and auxiliary functions for PROBEAT-V
    MEVION S250i Proton Beam Radiation Therapy Device
    Real Time Image Gating System for Proton Beam Therapy Systems
    IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)
    Anzai Respiratory Gating System
    ProNova SC360 Proton Therapy System
    Sumitomo Proton Therapy System
    Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)
    PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory
    Anzai Respiratory Gating System
    PROBEAT-V and accessories
    McLaren Proton Therapy System
    PROBEAT-V
    Extended Range Shifter for PROBEAT-V
    PROBEAT-V
    GANTRY BEAM LINE
    VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE
    RADIANCE 330 PROTON THERAPY SYSTEM
    PROBEAM PROTON THERAPY SYSTEM
    I2C
    SUMITOMO PROTON THERAPY SYSTEM
    VERIFICATION CONSOLE
    S-250 PROTON BEAM RADIATION THERAPY SYSTEM
    AIR-BAG SYSTEM
    SUN 125C IONIZATION CHAMBER
    CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING
    PT2 VARIAN PROTON THERAPY SYSTEM
    CALYPSO SYSTEM WITH DYNAMIC EDGE GATING
    MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235
    IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235
    PROTON THERAPY MULTILEAF COLLIMATOR
    IBA PROTON THERAPY SYSTEM, PROTEUS 235
    VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8
    PROTEUS 235 PROTON THERAPY SYSTEM
    IBA PROTON THERAPY SYSTEM - PROTEUS 235

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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