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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: EAM FDA class 1

    Screen, Intensifying, Radiographic

    Radiology

    View full classification →

    The Radiographic Intensifying Screen is an imaging accessory placed in contact with X-ray film inside a cassette to convert X-ray photons into visible light, thereby reducing the radiation dose required to produce a diagnostic-quality radiographic image. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EAM and the applicable regulation is 21 CFR 892.1960, under the Radiology medical specialty.

    510(k) Clearances

    35 matches
    K Number
    Device Name
    ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL
    MD100 & MM150
    JPI INTENSIFYING SCREEN
    KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC
    FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12
    FUJI UM MAMMO SERIES INTENSIFY SCREENS:
    KYOKKO GREEN SERIES INTENSIFYING SCREENS
    FUJI HG-M INTENSIFYING SCREEN
    KODAK INSIGHT TWIN-LOAD INSERT
    KYOKKO BLUE SERIES INTENSIFYING SCREENS
    KYOKKO UM SERIES INTENSIFYING SCREEN
    RAREX GREEN FAST
    ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN
    MICROVISION FAST DETAIL INTENSIFYING SCREEN
    ULTRA-VISION RAPID INTENSIFYING SCREEN
    ULTRA-VISION DETAIL INTENSIFYING SCREEN
    ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN
    PERLINK SCREEN, KIRAN SCREEN
    RAREX & OPTEX X-RAY SCREENS
    RADIOGRAPHIC INTENSIFYING SCREEN
    CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN
    CRONEX QUANTA SUPER RAPID SR339 RARE EARTH
    CRONEX QUANTA SR300 INTENSIFYING SCREEN
    CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN
    KODAK MIN-R MEDIUM SCREEN
    FUJI CR IMAGING PLATE
    KODAK MIN-R FAST SCREEN SO-459
    CRONEX SR342-QUANTA FAST DETAIL-INTENSI-SCREENS
    CRONEX SR-337
    KODAK INTENSIFYING SCREEN 80-175
    KODAK INTENSIFYING SCREEN SO-168
    KODAK LANEX MED. SCREEN
    SCREEN, FINE, LANES, KODAK
    CRONEX QUANTA III INTENSIFYING SCREENS
    FLUORICON 500 IMAGE INTENSIFIERS

    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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