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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: IYE FDA class 2

    Accelerator, Linear, Medical

    Radiology

    View full classification →

    A medical linear accelerator is a device used in radiation therapy to deliver high-energy X-ray or electron beams for the treatment of cancer and other tumors. It falls under FDA Class 2, indicating moderate risk; manufacturers must submit a 510(k) premarket notification demonstrating substantial equivalence to a legally marketed predicate device before marketing. The product code is IYE, regulated under 21 CFR 892.5050, within the Radiology medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Cranial 4Pi Immobilization
    MapRT
    Mobius3D (4.1)
    DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set
    Klarity SGRT System (ARSG-E1A, ARSG-E3A)
    Identify (4.0)
    ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface
    BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)
    Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)
    VenusX
    AlignRT Plus
    LUNA 3D
    ThinkQA (Edition 2)
    Delta4 Insight
    ArcherQA (V1.0)
    kallisio stentra™ oral stent
    TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)
    BinkieRT
    Halcyon, Ethos Radiotherapy System
    TrueBeam, TrueBeam STx, Edge, VitalBeam
    IDENTIFY
    AccuCheck
    Radixact Treatment Delivery System
    MapRT
    SIDDHARTH-II;IMPACT
    TrueBeam, TrueBeam STx, Edge, VitalBeam
    ExacTrac Dynamic 1.1.2
    ARIA Radiation Therapy Management (v18.0)
    Iris AirShuttle™
    MOSAIQ® OIS (Oncology Information System)
    Elekta Unity
    DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip
    Halcyon, Ethos Radiotherapy System
    Klarity SRS Baseplate, Klarity Promise Baseplate
    ClearCheck Model RADCC V2
    FlexBoardTM, EagleBoardTM, BreastBoard SXTM
    ARIA Radiation Therapy Management (v16.1 MR3)
    ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)
    TrueBeam, TrueBeam STx, Edge, VitalBeam
    INTDose
    VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips
    Aurora-RT
    ExacTrac Dynamic
    VERIQA
    Gold Anchor
    MRIdian Linac System
    AlignRT Plus
    TaiChiB
    Elekta Unity
    Accuray Precision Treatment 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
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