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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: KPR FDA class 2

    System, X-Ray, Stationary

    Radiology

    View full classification →

    This device is a stationary x-ray system used for diagnostic imaging across a wide range of clinical applications including skeletal, thoracic, and abdominal radiography. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPR, regulated under 21 CFR 892.1680 within the Radiology specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    DRE Duo
    AeroDR TX c02
    DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
    uDR Arria & uDR Aris
    uDR Aurora CX
    Definium Tempo Select
    INNOVISION-DXII
    YSIO X.pree
    GXR-Series Diagnostic X-Ray System
    Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))
    INNOVISION-EXII
    uDR 780i
    EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);
    Definium Pace Select ET
    GF85 (models GF85-3P, GF85-SP)
    EOSedge
    EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)
    Radiography 7300 C
    YSIO X.pree
    FDR Visionary Suite
    DRX-Evolution Plus System
    RADspeed Pro
    MULTIX Impact E
    XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50
    PodSKAN HF Diagnostic X-ray System
    AcuityUDR
    GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)
    Definium Pace Select
    DMX
    Jumong General
    DRX - Compass
    DigiX FDX
    OTC DDR
    MULTIX Impact E
    Hand Diagnostic Radiography Imaging System
    General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)
    SKANRAD 400
    ExamVue Duo
    Straight Arm DDR
    MULTIX Impact, MULTIX Impact C
    Philips Radiology Smart Assistant
    DigitalDiagnost
    Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems
    MULTIX Impact
    MULTIX Impact C
    Apolo D / Apolo S
    MiniCAT 2D
    YSIO X.pree
    Radiographic System Challenge X
    GXR-Series Diagnostic X-Ray 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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