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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: NQQ FDA class 2

    System, Imaging, Optical Coherence Tomography (Oct)

    Radiology

    View full classification →

    The optical coherence tomography (OCT) imaging system is a radiology device that uses back-reflected light to create high-resolution two-dimensional cross-sectional images of biological tissues, analogous to ultrasound but using light rather than sound waves, with applications in ophthalmic imaging and other specialties. It is classified as FDA Class 2 under regulation 892.1560 in the Radiology specialty, requiring 510(k) clearance. Product code NQQ is eligible for third-party review and is not an implant or life-sustaining device.

    510(k) Clearances

    41 matches
    K Number
    Device Name
    OPUSWAVE Dual Sensor Imaging System
    OPXION Optical Skin Viewer (OPXSV1-01F)
    Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)
    Starlight Imaging Catheter
    HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))
    deepLive
    ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6
    HyperVue™ Imaging System
    SpectraWAVE Imaging System
    OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
    OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
    ApolloVue S100 Image System
    Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
    NvisionVLE Low-profile Optical Probe
    Ilumien Optis, Optis Integrated, Optis Mobile
    OTIS Optical Coherence Tomography SYstem
    NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
    NvisionVLE Imaging System, NvisionVLE Optical Probe
    OTIS Optical Coherence Tomography System
    LuminScan (TM) Imaging System
    VivoSight Dx Topical OCT System
    OPTIS Metallic Stent Optimization E.4 SW
    Perimeter Otis™ 1.0 Optical Coherence Tomography System
    NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
    OPTIS Mobile System
    OPTIS Integrated System Mobile Workstation
    ILUMIEN OPTIS
    ILUMIEN, Drageonfly OPTIS Imaging Catheter
    NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
    FORESEE (4C) IMAGING SYSTEM
    SKINTELL
    NVISION VLE IMAGING SYSTEM
    ILUMIEN OPTIS
    NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
    NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER
    C7 XR IMAGING SYSTEM
    TOMOPHASE OCTIS
    C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES
    VIVOSIGHT TOPICAL OCT SYSTEM
    IMALUX NIRIS IMAGING SYSTEM
    IMALUX OCT IMAGING SYSTEM

    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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