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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: KGI FDA class 2

    Densitometer, Bone

    Radiology

    View full classification →

    Bone Densitometer is a diagnostic imaging or measurement device used to assess bone mineral density, primarily for the diagnosis and monitoring of osteoporosis and related metabolic bone diseases, and to evaluate fracture risk in patients. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KGI, regulated under 21 CFR 892.1170, within the Radiology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BunkerHill BMD
    TBS iNsight (V4)
    VirtuOst
    3D-SHAPER
    ABMD Software
    GEHC DXA Bone Densitometers with enCORE version 18
    Aria
    GE Lunar DXA Bone Densitometers with enCORE version 17
    TBS iNsight
    QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT
    ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS
    SINGLE ENERGY (SE) FEMUR EXAMS
    TBS INSIGHT
    VIRTUOST
    ACCUDXA2
    ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS
    HOLOGIC VISCERAL FAT SOFTWARE
    GE LUNAR VISCERAL FAT SOFTWARE
    NHANES WHOLE BODY DXA REFERENCE DATABASE
    TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS
    GE LUNAR FEMUR STRENGTH SOFTWARE
    OSDX HIP BMD SYSTEM
    GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION
    1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION
    APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS
    GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT
    GE LUNAR BODY COMPOSITION SOFTWARE
    HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS
    IVA (MXA II SOFTWARE OPTION)
    LUNAR IDXA
    INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS
    PEDIATRIC REFERENCE DATABASE
    DXL CALSCAN
    HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
    DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS
    DPX SERIES BRAVO DUO BONE DENSITOMETER
    CTXA HIP EXTENDED REFERENCE DATA
    DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE
    HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
    SECTRA OSTEOPOROSIS PACKAGE
    DEXACARE G4
    CTXA HIP; CTXA; QCT PRO CTXA HIP
    ADVANCED HIP ASSESSMENT SOFTWARE
    X-POSURE SYSTEM VERSION 2 MAMMO
    X-POSURE SYSTEM VERSION 2 RAD
    HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER
    PEDIATRIC REFERENCE DATA
    LUNAR REPORT GENERATOR II
    MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY
    MODIFICATION TO ACCUDEXA BONE DENSITOMETER

    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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