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510(k) Data Aggregation

    K Number
    K240648
    Device Name
    Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)
    Manufacturer
    Radiant Innovation Inc.
    Date Cleared
    2024-06-05

    (90 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Radiant Innovation Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The non-contact forehead thermometer is an electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from forehead center in people of all ages.
    Device Description
    The thermometer (Mode: TH48FE, TH09F, THD2FE) are electronic thermometer using an IR sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to an oral temperature value. The thermometer consists of an IR sensor with a built-in ambient temperature sensor, Application-Specific Integrated Circuitry including software, LCD display, buttons, and batteries.
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    K Number
    K163601
    Device Name
    RII Smart IR Thermometer
    Manufacturer
    RADIANT INNOVATION INC.
    Date Cleared
    2018-12-06

    (715 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIANT INNOVATION INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RII Smart IR Thermometer, Model TMS-01A is a non-contact infrared forehead thermometer and can only be used with an APP since the display only on a device with the APP. It is intermittent measurement of human body temperatures and is to be used at home for people of all ages.
    Device Description
    The RII Smart IR Thermometer, Model TMS-01A is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from center of forehead. The principle of operation is based on measuring the natural thermal radiation from the center of forehead. The thermometer consists mainly of two parts - an IR sensor with a built-in ambient temperature sensor and an associated circuit. TMS-01A can only be used with an APP called "Radiant Forehead" which is available on APP store for iOS devices with version 7.0 or above. The APP is designed for use with TMS-01A to take forehead temperature by plugging the TMS-01A in the phone jack of the iOS devices. To measure body temperature, simply aim the device within 1 cm from the center of forehead. Press the "MEASURE" button on the smart phone touch screen, the temperature sensor detects the infrared thermal energy emitted from the targeted area. The electrical signal is sent to the circuit for amplification and calculation. The final measured temperature can be display on smart phone. The time consuming for measurement might be 1 second.
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    K Number
    K162083
    Device Name
    RII Multi-function Infrared Thermometer, Model TH52Z
    Manufacturer
    Radiant Innovation Inc.
    Date Cleared
    2017-01-09

    (166 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Radiant Innovation Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RII Multi-function Infrared Thermometer, Model TH52Z is intermittent measurement of human body temperatures. The device is intended for the use at home by people of all ages including neonates and it can be selected Ear mode or Forehead mode.
    Device Description
    The RII Multi-function Infrared Thermometer, Model TH52Z is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal or central forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or central forehead. The end of ear canal is the tympanic membrane, which is thin and flooded with blood at the core temperature. The central forehead skin is thin & flat, and the temperature is uniform to cover the Whole FOV (Field of View) of the sensor. The thermometer consists mainly of two parts - an IR sensor with a built-in ambient temperature sensor and the associated circuit. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.
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    K Number
    K121428
    Device Name
    NON-CONTACT CLINICAL THERMOMETER
    Manufacturer
    RADIANT INNOVATION INC.
    Date Cleared
    2012-07-17

    (64 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIANT INNOVATION INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Non-contact Clinical Thermometer, Model THB0F is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
    Device Description
    The RII Non-contact Clinical Thermometer, Model THBOF is electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from the Forehead. Its operation is based on measuring the natural thermal radiation emanating from the temples to hairline upper eyebrows. The thermometer consists mainly of the following parts: an IR sensor with a built-in ambient temperature sensor, a thermo-mass, and the associated circuit. The forehead skin, which is thin and beneath, which is the temporal artery, with blood very near to the core temperature. The forehead skin must cover the whole FOV(Field of View) of the sensor. When measuring, radiation fluxes transfer from the skin to the IR detector. The ambient sensor is mounted in the IR sensor package, and near the IR detector element to monitor the ambient temperature. To measure core temperature, the probe of the thermometer are slide through the skin of the a patient's forehead. A activation button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appear on a LCD display. The total operation takes a few seconds.
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    K Number
    K101253
    Device Name
    RII INFRARED EAR THERMOMETER, MODEL: TH60N
    Manufacturer
    RADIANT INNOVATION INC.
    Date Cleared
    2010-06-29

    (56 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIANT INNOVATION INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
    Device Description
    The Radiant Innovation Inc., Infrared Ear Thermometer, Model TH60N is electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient. To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a LCD display. The total operation takes a few seconds. Radiant Infrared Ear Thermometer TH60N is an ear thermometer without probe cover with some sub-functions such as: temperature unit switchable, recall memory, scan function, last reading display, ambient temperature, and backlight.
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    K Number
    K070976
    Device Name
    RII INFRARED EAR THERMOMETER, MODEL TH01BN
    Manufacturer
    RADIANT INNOVATION INC.
    Date Cleared
    2007-04-20

    (14 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIANT INNOVATION INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
    Device Description
    The Radiant Innovation Inc., Infrared Ear Thermometer, Model TH01BN are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient. To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a LCD display. The total operation takes a few seconds.
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    K Number
    K051269
    Device Name
    RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES
    Manufacturer
    RADIANT INNOVATION INC.
    Date Cleared
    2005-09-09

    (115 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIANT INNOVATION INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is an electronic clinical thermometer using an infrared sensor to detect body temperature. The device is intended for use on the pediatric and adult population used in the home setting.
    Device Description
    The Radiant Innovation Inc., Infrared Ear Thermometer, Models TH00XY series are electronic clinical thermometers using an infrared detector (thermopile detector) to detect electromagnetic radiation. The operation is based on measuring the body temperature from the auditory canal from the tympanic membrane and the adjacent surfaces of the patient. To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A Start button is pressed to start the measurement through the radiation exchanges. The measured temperature then appears on a LCD display. The total operation takes a few seconds.
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