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510(k) Data Aggregation

    K Number
    K172427
    Device Name
    AViTA Radar Thermo NT16 Series IR Thermometer
    Manufacturer
    Avita Corporation
    Date Cleared
    2018-04-19

    (252 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K081160
    Why did this record match?
    Reference Devices :

    K081160

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    AViTA Radar Thermo NT16 Series IR Thermometer is an infrared thermometers intended for the intermittent measurement of human body temperature from the forehead in people of all ages.

    Device Description

    AViTA Radar Thermo NT16 Series IR Thermometer is hand-held and battery-operated, taking skin temperature mainly in the middle of the forehead. The AVITA Radar Thermo NT16 Series IR Thermometer uses the principle of surveying the natural emission of infrared thermal radiation from the forehead of human body.

    AI/ML Overview

    1. Table of Acceptance Criteria and Reported Device Performance:

    FeatureAcceptance Criteria (from Subject Device)Reported Device Performance (from Subject Device)
    Accuracy (Human Body)± 0.2 °C for 34°C ~ 43 °CMeets ASTM E1965, ISO 80601-2-56 (Implied that the device performs within this range)
    Precision (SD)
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