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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: OXO FDA class 2

    Image-Intensified Fluoroscopic X-Ray System, Mobile

    Radiology

    View full classification →

    The Image-Intensified Fluoroscopic X-Ray System, Mobile is a portable radiology device used for real-time fluoroscopic imaging of the human body in clinical settings such as operating rooms and emergency departments. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance, and is eligible for third-party review. The product code is OXO, with regulation number 892.1650 under the Radiology medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Orthoscan TAU Mini C-Arm
    Orthoscan VERSA Mini C-Arm
    OEC One ASD
    OEC 3D
    Orthoscan Tau Mini C-Arm
    OEC 3D
    OEC Elite
    Smart-C
    OrthoScan TAU Mini C-Arm
    OEC One
    Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant
    OEC Elite
    OEC Elite MiniView
    B6
    MultiScan G-Arm System
    OEC Elite MiniView
    GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
    MultiScan G-Arm System
    DIGIARC 100AU+
    ORTHOSCAN FD MINI C-ARM
    G-ARM MULTISCAN SYSTEM
    OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME
    MOBILE C-ARM
    INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
    OEC 9900 ELITE
    ORTHOSCAN MOBILE DI MINI C-ARM
    O-ARM IMAGING SYSTEM
    VERT-X
    O-ARM IMAGING SYSTEM
    ORTHOSCAN, ORTHOSCAN HD
    GE OEC EVERVIEW 7500
    ARCADIS AVANTIC
    O-ARM IMAGING SYSTEM
    SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200
    3DSCOPE
    SIREMOBIL ISO-C 3D
    SIREMOBILE C06
    XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM
    MOONRAY MOBILE C-ARM
    PHILIPS BV LIBRA
    APOLLO MOBILE C ARM SYSTEM
    FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM
    XISCAN 6000 IMAGING SYSTEM
    SIREMOBIL ISO-C 3D
    SONADA ULTRASOUND SYSTEM
    MINI 6800 DIGITAL MOBILE C-ARM
    XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM
    PHILIPS BV300 SERIES RELEASE 2.1
    PATHFINDER MOBILE C ARM
    ACCENT 16, ACCENT 22

    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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