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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: IWB FDA class 2

    System, Radiation Therapy, Radionuclide

    Radiology

    View full classification →

    A radionuclide radiation therapy system is a complete device system used to deliver therapeutic doses of radiation from radioactive isotopes to treat malignant and other conditions, encompassing the source handling, positioning, and delivery mechanisms. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IWB, regulated under 21 CFR 892.5750, within the Radiology medical specialty.

    510(k) Clearances

    48 matches
    K Number
    Device Name
    Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)
    Leksell GammaPlan (LGP)
    Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
    TaiChiC
    Akesis Galaxy RTi
    Akesis Galaxy RTx
    Akesis Galaxy
    GammaPod
    Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon
    Leksell GammaPlan
    GammaPod - Model A
    Leksell Gamma Knife Icon
    Leksell Gamma Knife Perfexion
    Leksell Gamma Knife Icon
    GammaBeam 500
    GammaBeam 100
    LEKSELL GAMMA KNIFE PERFEXION
    HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM
    LEKSELL GAMMA KNIFE PERFEXION
    ROTATING GAMMA SYSTEM INFINI (INFINI)
    EXTEND FRAME SYSTEM, MODEL 1009633
    LEKSELL GAMMA KNIFE PERFEXION
    LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000
    LEKSELL GAMMAPLAN
    ROTATING GAMMA SYSTEM. GAMMA ART-6000
    THERATRON EQUINOX, MODELS 80 CM AND 100 CM
    GAMMAPLAN
    MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM)
    THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE
    THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1
    THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
    LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001
    THERATRON ELITE
    LEKSELL GAMMAPLAN
    THERATRON 780E
    OUR ROTATING GAMMA SYSTEM
    THE COBALT SCALPEL
    LEKSELL GAMMA UNIT MODEL 23004,TYPE B.
    DPD-510 THERAPEUTIC RADIATION DOSIMETER
    LEKSELL GAMMAPLAN (LGP)
    ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES
    THERATRON 1000
    DISPOSABLE SHADOW TRAY INSERTS
    THERATRON-PHOENIX
    MARX PLAN, RADIATION THERAPY TREATMENT PLAN SYSTEM
    THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY
    STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE
    SYSTEM, PLANNING, TREATMENT

    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
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