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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: IZI FDA class 2

    System, X-Ray, Angiographic

    Radiology

    View full classification →

    An angiographic X-ray system is used to visualize blood vessels and cardiac structures by imaging the passage of contrast medium through the vascular system, supporting diagnosis and interventional procedures in cardiology and radiology. It is classified as FDA Class 2, reflecting moderate risk and a 510(k) premarket clearance requirement. The product code is IZI, regulated under 21 CFR 892.1600, within the Radiology medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Affirm 800
    Modus IR
    EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)
    Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
    SPY Portable Handheld Imaging (SPY-PHI) System
    EXPLORER AIR® II
    Explorer Air II
    DIR 800
    Asimov-MKS Imaging System
    SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
    SPY Elite Intraoperative Perfusion Assessment System
    GLOW800
    CAAS Workstation
    YELLOW 560 Fluorescence Module
    Leica FL560
    CAAS Workstation
    LEICA FL800
    PDE-NEO
    CAAS WORKSTATION
    XIRALITE FLOURESCENCE IMAGING SYSTEM X4
    ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES
    C-THV SYSTEM
    GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM
    INTEGRATED INNOVA - S5I SYSTEM OPTION
    THE IC-PRO SYSTEM
    SPY INTRA-OPERATIVE IMAGING SYSTEM
    SYNC-RX SYSTEM, MODEL AS00010
    ZEISS INFRARED 800 WITH FLOW 800 OPTION
    ARTIS ZEE / ZEEGOS WITH SW VC14
    THE IC-PRO SYSTEM, MODEL VERSION 3.2
    IC-PRO SYSTEM, VERSION 3.1.0.4
    CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA
    LEICA FL800
    ARTIS ZEE AND ZEEGO
    SPY FLUORESCENT IMAGING SYSTEM
    SPY FLUORESCENT IMAGING SYSTEM
    SPY FLUORESCENT IMAGING SYSTEM
    CARDIOP-B SYSTEM, VERSION 2.1
    SPY FLUORESCENT IMAGING SYSTEM
    DAR-9400F
    GE OEC ALTITUDE
    SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000
    SPY IMAGING SYSTEM
    BRANSIST SAFIRE
    LEICA MODEL FL800
    SPY INTRAOPERATIVE IMAGING SYSTEM
    XPERCT
    DAR-8000F
    DAR-8000I
    GE OEC ALTITUDE

    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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