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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: IZH FDA class 2

    System, X-Ray, Mammographic

    Radiology

    View full classification →

    A mammographic X-ray system is specifically designed for imaging breast tissue at low radiation doses, used for the detection and diagnosis of breast cancer and other abnormalities. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification before it can be marketed. The product code is IZH, regulated under 21 CFR 892.1710, within the Radiology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SMART FINDER
    Affirm Contrast Biopsy
    Biopsy Positioner
    Affirm Lateral Arm Upright Biopsy Accessory
    Comfort Cover
    Affirm Prone Biopsy System
    MammoGRIP
    AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
    SPECBOARD JR.
    BIOPSY DIGIT S BIOPSY SL
    BIOPSY POSITIONER
    AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
    EMBRACE
    DIGITAL SPOT MAMMOGRAPHY SYSTEM
    BELLA
    BEMITT, MODEL 0001
    DIGITAL STEREOLOC II
    LIV BREAST SELF EXAMINATION AID
    BIOPSY DIGIT-AM
    TRAXYLOC-1 SYSTEM
    PLANMED SOPHIE NUANCE CLASSIC
    MAMMOTEST
    LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
    SENOGRAPHIC STEREO
    ADVANTAGE PADDLE
    SQUEEZE-EASE MAMMOGRAPHY CUSHION
    MULTICARE PLATINUM SYSTEM AND ACCESSORIES
    PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
    PERFORMA STEREO
    S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE
    DELTA 32; DELTA 32 TACT
    BREAST BOLSTER
    PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
    GIOTTO IMAGE
    MODIFIED 650 MAMMOGRAPHY SYSTEM
    MODIFIED M-IV MAMMOGRAPHY SYSTEM
    MAMMOGRAPH
    PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
    BIOLUCENT MAMMOGRAPHY CUSHION
    OPDIMA
    DELTA 32 AND DELTA 32 TACT
    DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM
    DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)
    DELTA 16 TACT
    DIGITEC TWO STAGE COMPRESSION KIT
    MAMEX
    LORAD 1-650 (INTERNATIONAL 650)
    PLANMED SOPHIE AND SOPHIE CLASSIC
    MAMEX
    BIOPSY-DIGIT

    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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