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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
    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™
    IntraOp Alignment System
    Zenition 90
    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
    XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
    Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
    EXTRON 5; EXTRON 7
    Oscar 15 & Oscar 15i
    Ziehm Vision RFD 3D
    F3
    ANT-X System
    nView s1 with nav option
    Cios Select (VA21) Flat Panel
    Cios Select (VA21) Image Intensifier
    Bolt Navigation System
    Multitom Rax
    EndoNaut
    Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
    Shield System
    XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3
    TRON
    Trinias
    ARTIS icono (Ceiling Configuration)

    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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