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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: KPQ FDA class 2

    System, Simulation, Radiation Therapy

    Radiology

    View full classification →

    This device is a radiation therapy simulation system used to plan and verify the delivery of radiation treatment, enabling clinicians to define target volumes and confirm beam positioning before actual therapy sessions. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPQ, regulated under 21 CFR 892.5840 within the Radiology specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION
    ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS
    RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER
    ONCENTRA SIMULATION 2.3
    IKOENGELO, VERSION 2
    INTEGRATED BRACHYTHERAPY UNIT - DIGITAL
    IKOENGELO
    SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM
    ADVANTAGE SIM MD
    SIMULIX EVOLUTION
    ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY
    EXOMIO, MODEL 2.0 SP1
    ACUITY RADIATION THERAPY SIMULATOR
    EXOMIO, MODEL 1.1
    ADVANTAGE SIM 6.0
    QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00
    SOMAVISION
    HELAX-IMCON, VERSION 1.0
    IBU, INTEGRATED BRACHY THERAPY UNIT
    VARIAN RADIATION THERAPY IMAGING SYSTEM
    SHADOWFORM
    VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE
    SIMVIEW 3000 CT OPTION
    MODEL 555 010 XY CONVERSION(55010)
    ADVANTAGE SIM
    CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY
    SIMULIX-HP
    SIMVIEW(TM) 3000
    MODEL ASYM-100
    CMS RECORD AND VERIFY
    ACQSIM SIMULATOR/LOCALIZER
    E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS
    CONTOURING DEVICE
    MKS BEAM OUTLINE PROJECTOR
    SCANDIPLAN - VERSION 338
    MODULEX RTP SYSTEM
    RAHD 3100
    XIMATRON/CT OPTION
    AUTOCOMP
    OLDELFT SIMULIX-MC
    COMPUTE-RX-COMP (TM)
    CTS COMPUTED TOMOGRAPHY (CT) ATTACHMENT
    NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM
    GE TARGET SERIES 2
    THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL
    PROWESS 2000
    SLS SIMULATOR (MODELS SLS-9 AND SLS-14)
    XIMAVIEW(TM)
    SIMRITE VERIFICATION AND SIMULATION SYSTEM
    MHTI CT-SIM RADIATION THERAPY TREATMENT SIMULATOR

    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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