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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: LHQ FDA class 1

    System, Telethermographic (Adjunctive Use)

    Obstetrics/Gynecology

    View full classification →

    A telethermographic system for adjunctive use is a thermal imaging device that produces infrared temperature maps of the body surface and is intended to be used alongside other diagnostic methods rather than as a standalone screening tool. The device is FDA Class 1, the lowest risk category, requiring only general controls. It carries product code LHQ and is regulated under 21 CFR 884.2980 within the Obstetrics/Gynecology specialty. No special flags apply to this device.

    510(k) Clearances

    40 matches
    K Number
    Device Name
    ThermPix Thermovisual Camera
    ThermPix Thermovisual Camera
    Smile-100 System
    IRIS-XP
    Thermidas IR System (ThIR-A615)
    InTouch Thermal Camera
    Med-Hot Thermal Imaging Systems
    Sentinel BreastScan II System
    FirstSense Breast Exam
    AlfaSight 9000 Thermographic System
    NOTOUCH BREASTSCAN
    AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301
    ICI P AND S SERIES IR CAMERAS
    MEDHOT MTI 2000 THERMAL IMAGING SYSTEM
    EMD THERMOGRAPHY SYSTEM
    TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P
    INFRARED SCIENCES BREASTSCAN IR SYSTEM
    TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM
    THERMATREK IRIS-IV INFRARED IMAGING SYSTEM
    MHS 7000
    MARK I THERMAL IMAGER
    DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM
    TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB
    MHS 5000
    MEDITHERM MED2000
    REGUTHERM 952 THERMOGRAPHIC SYSTEM
    OMNICORDER BIOSCAN SYSTEM
    THERMATREK IRIS-3 INFRARED IMAGING SYSTEM
    INFRAMETRICS INFRACAM-MED
    CRT2000 THERMOGRAPHIC SYSTEM
    OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000)
    BSI MODEL TIP
    THERMO-5000
    PM-100 THERMOGRAPH MARK 1026
    MODEL 450 INFRARED IMAGING SYSTEM
    GST SYSTEM THERMOGRAPHIC APPLICATION
    BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM
    INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM
    PROBEYE THERMAL VIDEO SYSTEMS
    INFRA-EYE 160

    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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