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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: IZL FDA class 2

    System, X-Ray, Mobile

    Radiology

    View full classification →

    A mobile X-ray system is a portable diagnostic radiographic unit mounted on a wheeled base, enabling bedside imaging of patients who cannot be transported to a fixed radiographic suite, commonly used in intensive care and surgical settings. It is classified as FDA Class 2, reflecting moderate risk and a requirement for 510(k) premarket notification. The product code is IZL, regulated under 21 CFR 892.1720, within the Radiology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Portable DR Imaging System
    RAYMO Mobile X-ray System (Model: RAYMO)
    Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
    AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
    Airbile-100
    Mobile X-ray unit (!M1)
    BONX805
    PROMO
    HnX-P1, HnX-PB
    REMEX Xcam6
    PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS
    INNOVISION-P5
    Europa (Alternative: AiRTouch) portable X-ray system
    !M1
    ULTRA 1040
    TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)
    DRX-Revolution Mobile X-ray System
    Digital Radiography System (ManntiX B, ManntiX K)
    uDR 380i Pro
    GM85
    ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)
    iQFlex Pro
    Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)
    Radiography 7000 M
    SM-IV
    TOPA12 Portable X-ray Unit
    MOBILETT Impact
    AirRay
    SM-V
    Combined High Frequency X-ray Source
    uDR 380i Pro
    GM85
    CLAROX plus (Model: VX-100)
    PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.
    MINE ALNU (Model: Mine 2.1)
    iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System
    Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine
    GM85
    APX-24 Portable X-ray System
    DRX-Rise Mobile X-ray System
    Skanmobile, Skanmobile-Dr
    EzRay M18 (Model: VMX-P400)
    Micro C Medical Imaging System, M01
    MOVIX DReamy
    PHOENIX
    Diagnostic X-ray System/PLX5200A
    NFLK-2501 Portable X-ray Unit
    Remex KA6
    Micro C Medical Imaging System, M01
    Rover

    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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