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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: JAA FDA class 2

    System, X-Ray, Fluoroscopic, Image-Intensified

    Radiology

    View full classification →

    An image-intensified fluoroscopic X-ray system uses an electronic image intensifier to amplify the fluoroscopic image, enabling real-time visualization of dynamic processes such as contrast studies, catheterizations, and interventional procedures at reduced radiation doses. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JAA, regulated under 21 CFR 892.1650, within the Radiology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Soteria E-View
    Adora DRFi (04550010)
    TRIDENT Mobile Fluoroscopy System
    ProxiDiagnost N90 / Precision CRF (706110, 706400)
    CombiDiagnost R90
    XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
    Nautilus
    Nyquist.IQ
    ProxiDiagnost N90
    DR 800 with DSA, DR 800
    Insight Agile DRF
    Ziehm Vision RFD
    Platinum dRF Imaging System
    XR-MX/1000
    CombiDiagnost R90
    ArtPIX DRF
    Insight Enhanced DRF Digital Imaging System
    CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)
    PowerDR
    FLUOROspeed
    Insight Essentials DRF Digital Imaging System
    CS-series-FP with Optional ROI Accessory CA-100S
    SonialVision G4
    MECALL CLISIS SYSTEMS, Discovery RF180
    Uroview FD II
    DR 800 with MUSICA Dynamic
    Philips CombiDiagnost R90
    Uroview FD
    Platinum dRF Imaging System
    D2RS_AT Digital Dynamic Remote System
    GENESIS
    X-RAY TV SYSTEM SONIALVISION G4
    GENESIS II
    OPERA SWING
    XIDF-AWS801, ANGIO WORKSTATION, V5.31
    GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM
    KALARE
    X-RAY TV SYSTEM SONIAL VISION G4
    PLATINUM DRF IMAGING SYSTEM
    ZIEHM VISION RFD
    INFINIX ANGIO WORKSTATION W/DTS SOFTWARE
    NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)
    DOSE TRACKING SYSTEM MODEL XIDF-DTS801
    GENESIS
    CS-SERIES-FP WITH 3030+OPTION
    INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V
    LUMINOS AGILE
    KALARE DIAGNOSTIC X-RAY TABLE SYSTEM
    DUET DRF
    UROSKOP OMNIA

    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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