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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: MUE FDA class 2

    Full Field Digital, System, X-Ray, Mammographic

    Radiology

    View full classification →

    A Full Field Digital Mammographic X-Ray System is a specialized radiographic imaging system that captures digital X-ray images of the entire breast for breast cancer screening and diagnosis, replacing traditional film-based mammography with digital detectors for improved image quality and processing flexibility. It is FDA Class 2, requiring 510(k) clearance, with product code MUE under 21 CFR 892.1715 in the Radiology specialty. The device is not an implant and is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    2430TCA with Xmaru W
    VIVIX-M
    MAMMOMAT B.brilliant
    RMF-2000
    Planmed Clarity 2D, Planmed Clarify S
    Aspire Cristalle
    Digimamo D
    Helianthus
    Senographe Pristina
    SenoBright HD
    2430MCA with Xmaru W
    Planmed Clarity 2D and Clarity S
    Giotto Class (Models - 3000X-YY and 4000X-YY)
    MAMMOMAT Revelation
    Pristina Serena Bright
    Sample Imaging for Senographe Pristina
    Pristina Serena 3D
    Pristina Serena
    Mammomat Revelation
    Planmed Clarity
    SenoBright HD
    ASPIRE Cristalle
    Adani MammoScan
    Senographe Pristina
    RSM 2430C
    RSM 1824C with RConsole1
    Mammomat Fusion with Stereotactic Biopsy
    Senographe Pristina
    MAMMOMAT Fusion
    ASPIRE CRISTALLE
    MICRODOSE SI
    SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)
    MAMMOMAT INSPIRATION PRIME
    ICRCO 3600M
    MAMMOMAL INSPIRATION
    MICRODOSE SI
    CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
    PLANMED NUANCE DIGIGUIDE
    ASPIRE HD PLUS, ASPIRE HD-S
    KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)
    PHILIPS MICRODOSE
    KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
    CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER
    SENOGRAPHE DS, SENOGRAPHE ESSENTIAL
    ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR
    GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L
    SENOGRAPH DS, SENOGRAPH ESSENSTIAL
    MAMMODIAGNOST DR
    PLANMED NUANCE EXCEL
    ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY 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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