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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: OWB FDA class 2

    Interventional Fluoroscopic X-Ray System

    Radiology

    View full classification →

    The Interventional Fluoroscopic X-Ray System is a radiology device used for real-time X-ray imaging guidance during interventional procedures such as catheter placements and vascular interventions. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket notification, and is eligible for third-party review. The product code is OWB, with regulation number 892.1650 under the Radiology medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    C-beam
    Intelligent NR
    ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno
    ARTIS genio floor; ARTIS icono.explore floor
    BELLIGER ACE
    Trinias
    Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
    CARA System
    ArmSure Fluoroscopic Positioning System
    Azurion R3.1
    MC2 Portable X-ray System
    SKAN C PULSAR
    Allia Moveo
    Cios Select
    Azurion R3.1
    Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
    Cios Spin
    Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
    LUMINOS Q.namix T; LUMINOS Q.namix R
    Cios Alpha; Cios Flow
    TAVIPILOT
    EXTRON 3; EXTRON 5; EXTRON 7
    Diagnostic X-ray System
    MasteRad MiniX Mobile Digital Imaging System (Mini-X)
    Persona C HR
    uAngio AVIVA CX
    ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)
    Ziehm Solo FD
    Ziehm Vision FD
    3DXR
    Ziehm Vision RFD 3D
    Ziehm Vision RFD
    MC2 Portable X-ray System
    ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)
    Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5
    O-arm O2 Imaging System
    See Factor CT3™
    Zenition 90
    IntraOp Alignment System
    DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl
    CIARTIC Move (VB10)
    Zenition 30
    Ziehm Vision RFD
    Ziehm Vision FD
    Ziehm Solo FD
    ARTIS pheno (VE30A)
    Ziehm Vision FD
    ARTIS icono (VE30A)
    Ziehm Solo FD
    Ziehm Vision RFD

    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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