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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: IXI FDA class 2

    Block, Beam-Shaping, Radiation Therapy

    Radiology

    View full classification →

    A radiation therapy beam-shaping block is a custom or modular attenuating block, typically made of high-density metal alloy, placed in the path of a therapeutic radiation beam to shape the treatment field and protect surrounding healthy tissue from unnecessary irradiation. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IXI, regulated under 21 CFR 892.5710, within the Radiology medical specialty. This device is eligible for third party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    VHA Radiotherapy Bolus
    VSP Bolus
    .DECIMAL PROTON APERTURE
    CURA COMPENSATOR
    CURA COLLIMATOR
    .DECIMAL PHOTON BLOCK
    APEX
    .DECIMAL ELECTRON APERTURE
    MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY
    BOLUS COMPENSATOR
    AXXENT FLEXISHIELD MINI
    .DECIMAL RANGE COMPENSATOR
    .DECIMAL APERTURE
    MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY
    TOPSLANE DMLC
    INNOCURE IMRT FILTER (COMPENSATORS)
    .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR
    MODIFICATION TO ACCULEAF
    MICROMLC
    MODULEAF
    PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY
    MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE
    MINI MULTILEAF COLLIMATOR, MODEL KMI
    LEAD BLOCKS
    DMLC IV-ERGO
    MOTORIZED MICRO MULTILEAF COLLIMATOR
    ENHANCED COMPENSATING FILTER
    ANGIO-CT MIYABI
    ELECTRON WEDGE MODEL MT-EW-1000
    AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM
    AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM
    AUTIMO 2.5-D AND AUTIMO 3-D
    AUTIMO
    SATURNE MULTILEAF COLLIMATOR
    SIEMENS BEAM SHAPER
    SIEMENS VIRTURAL WEDGE
    CASPER
    SIEMENS MULTILEAF COLLIMATOR
    MULTILEAF INTENSITY MODULATING COLLIMATOR
    FIELD ABUTMENT WEDGE
    360 DEG. ROTATING 1/2 BEAM BLOCK
    PHILIPS MULTILEAF COLLIMATOR (MLC)
    THE HUESTIS COMPU-PLOTTER
    VARIAN MULTILEAF COLLIMATOR
    DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST
    HUESTIS COMPU-FORMER
    PORTALCAST
    DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM
    CLARK PRECISION BLOCK CUTTER, COOLING
    MYVACET 5-07, 7-00 AND 9-40

    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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