BEUDAMED
    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: MUJ FDA class 2

    System, Planning, Radiation Therapy Treatment

    Radiology

    View full classification →

    A Radiation Therapy Treatment Planning System is a software-based medical device used to design individualized radiation therapy plans for cancer patients, calculating optimal beam arrangements, dose distributions, and treatment parameters to target tumors while minimizing radiation exposure to surrounding healthy tissues. It is FDA Class 2, requiring 510(k) clearance, with product code MUJ under 21 CFR 892.5050 in the Radiology specialty. The device is not an implant and is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    RadOncAI
    Multimodality Simulation Workspace (MM Sim) (v1.0.0)
    eXaSkin Plus
    ART.1-US
    syngo.via RT Image Suite VC10
    TrueFit Bolus
    Monaco RTP System (6.3)
    ART-Plan+ (v3.1.0)
    RayStation (2024A SP3)
    ClearCalc Model RADCA V2.6
    PlanOne 1
    Dose+ (1.0)
    RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT
    RayCare (2024A SP1)
    Oncospace
    RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
    ART-Plan+ (v.3.0.0)
    ARIA Radiation Therapy Management System (18.1)
    Eclipse Treatment Planning System (18.1)
    XBeam (v2)
    Vitesse (5.0)
    TrueFit Bolus; TrueFlex Bolus
    Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)
    Radiance V5
    syngo.via RT Image Suite
    ART-Plan (v.2.2.0)
    ART-Plan
    Panther TPS
    VariSeed (v10)
    MOZI TPS
    Eclipse Treatment Planning System (v18.0)
    Radiation Planning Assistant (RPA)
    RayStation 12A
    RT Elements (4.0)
    Monaco RTP System
    Oncospace
    syngo.via RT Image Suite
    MRI Planner
    ClearCalc Model RADCA V2
    Monaco RTP System
    RayStation 11B
    INT Contour
    MRCAT Head & Neck
    3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory
    RayStation 11.0
    AI Segmentation
    syngo.via RT Image Suite
    decimal Bolus
    RayStation 10.1
    Corvus Radiation Therapy Planning System

    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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump