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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: LNH FDA class 2

    System, Nuclear Magnetic Resonance Imaging

    Radiology

    View full classification →

    System, Nuclear Magnetic Resonance Imaging is a magnetic resonance imaging (MRI) system that uses strong magnetic fields and radiofrequency pulses to generate detailed cross-sectional images of the body's internal structures, widely used in diagnostic radiology for evaluating soft tissue, neurological, musculoskeletal, cardiovascular, and oncological conditions. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LNH, regulated under 21 CFR 892.1000, within the Radiology medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems
    MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
    MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
    Sonic DL
    Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
    Swoop® Portable MR Imaging® System (V2)
    uMR Omega
    Swoop® Portable MR Imaging® System
    SIGNA Prime Elite
    SureWave Elastography (Q7000225)
    Prenuvo Body Composition
    Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
    NIDO Baby Magnetic Resonance Imaging System
    SyMRI
    MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)
    SIGNA MAGNUS
    VitruvianScan (v1.0)
    MuscleView
    MyoStrain (6.0)
    Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
    ECHELON Synergy MRI System
    neo315
    Swoop® Portable MR Imaging® System
    Magnifico Open (100009900); Magnifico MSK ( 100009910)
    APERTO Lucent MRI System
    ECHELON Synergy V10.0
    uMR Jupiter
    OASIS MRI System
    Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR
    uMR 680
    MAGNETOM Viato.Mobile
    SyMRI
    MAGNETOM Terra; MAGNETOM Terra.X
    uMR Omega
    MAGNETOM Cima.X Fit
    InVision™ 1.5 Surgical Theatre
    neuro42 MRI System
    SIGNA Champion
    MAGNETOM Sola; MAGNETOM Altea
    MAGNETOM Cima.X
    fMRI Hardware System
    MAGNETOM Avanto fit; MAGNETOM Skyra fit
    MAGNETOM Free.Max; MAGNETOM Free.Star
    Digital Expert Access with Remote Scanning
    MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
    Synq Software Version 1.3
    Swoop® Portable MR Imaging System®
    Terran NM-101
    MAGNETOM Viato.Mobile
    Promaxo MRI System II

    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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