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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: IZO FDA class 1

    Generator, High-Voltage, X-Ray, Diagnostic

    Radiology

    View full classification →

    A diagnostic X-ray high-voltage generator is the power supply component of a radiographic system that converts electrical power into the precise high-voltage output required to produce diagnostic X-rays. It is classified as FDA Class 1, the lowest risk designation, subject only to general controls with no premarket notification requirement. The product code is IZO, regulated under 21 CFR 892.1700, within the Radiology medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    MPH50, MPH65, AND MPH80
    HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR
    N 800 HF
    SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G
    MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR
    POLYDOROS SX 65 AND 80
    COMPACT-X
    DIGITAL 625HF
    SII 360 APR
    UD 150L-F
    UD 150L-R II
    SII 525 APR
    HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS
    N 800 HF
    KXO-80G
    SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR
    MICRO X-80 HF
    MICRO X-50 HF
    MICRO X-30HF
    MICRO X-65 HF
    VASCULAR MP X-RAY GENERATOR
    RSX-525HF
    MODEL VPW2877F8, MAMMO 5 POWER SUPPLY
    MODEL TM EP HIGH VOLTAGE GENERATOR
    MOLYBDENUM/RHODIUM FILTERS
    SCPU X-RAY GENERATOR
    SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR
    CONCEPT ONE
    RADIOGRAPHIC GENERATOR HFQ-WHIS
    SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G
    PHILIPS XRG 90 X-RAY GENERATOR SYSTEM
    POLYDOROS IS
    POYDOROS LX
    LCR GENERATOR
    RSX 30HF
    ADVANTX SYSTEM
    MAGMA XHF-30, XHF-40, XHF-50
    PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR
    PCX 650HF RADIOGRAPHIC X-RAY
    OLYMP-X,X-RAY GENERATOR
    POLYDOROS C
    PHILIPS SUPER CP FAMILY
    PHILIPS MEDIO CP FAMILY
    POLYDOROS XS50 AND SX80
    X-RAY CONTROL AND HI-VOLTAGE GENERATOR
    TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT
    ATC725, ATC525, AND AP300
    MPG 65-80-100 X-RAY GENERATOR AND CONTROL
    P2900 X-RAY GENERATOR
    X-RAY HIGH VOLTAGE GENERATOR ED 125L

    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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