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510(k) Data Aggregation
K Number
K243778Device Name
Body Temperature Software (BTS)
Manufacturer
Date Cleared
2025-02-13
(66 days)
Product Code
Regulation Number
880.2915Why did this record match?
Product Code :
QZA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Body Temperature Software (BTS) App is a software-only mobile medical application intended for over-the- counter (OTC) use with compatible mobile computing platforms that includes a general purpose infrared sensor for the intermittent determination of human body temperature on people of all ages.
Device Description
The Body Temperature Software ("BTS") mobile application ("App"), is a Software as a Medical Device (SaMD) that leverages an infrared sensor from qualified compatible general computing platforms (i.e. Google Pixel Smartphone) to provide on-demand body temperature measurements. The BTS App is based on well understood infrared measurement technology. The app leverages consumer general purpose computing platforms to collect the inputs for measurement.
The BTS App is intended to be operated by users above 18 years of age and can be used to measure body temperature for themselves or other individuals. To collect the input temperature data, the user is guided to conduct a non-contact forehead sweep starting at the center of the forehead and ending at the temple, thereby passing over the temporal artery, which corresponds to the highest temperature point on the forehead. This temperature data is then used as an input into the BTS App to convert the measured skin temperature data into a body temperature value. Before and during this measurement process, the BTS App performs a series of signal quality checks to ensure the validity of the temperature data collected. Additionally, to aid users with the interpretation of their measurements, the BTS App also has the option to present users with a color-coded temperature quide to indicate if the measurement falls within normal limits or indicative of an elevated state based on wellrecognized body temperature ranges for the specified age of the individual being measured.
The BTS App collects the temporal artery temperature, which is processed using a polynomial function to approximate a rectal temperature.
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K Number
DEN230050Device Name
Body Temperature Software (BTS)
Manufacturer
Date Cleared
2023-12-15
(151 days)
Product Code
Regulation Number
880.2915Why did this record match?
Product Code :
QZA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Body Temperature Software (BTS) App is a software-only mobile medical application intended for over-the-counter (OTC) use with compatible mobile computing platforms that includes a general purpose infrared sensor for the intermittent determination of human body temperature on people of all ages.
Device Description
The Body Temperature Software (BTS) is a mobile medical application available to its intended users via their mobile device. The Body Temperature Software (BTS) collects and analyzes temperature data obtained via the infrared sensor built into the smartphone to approximate the user's rectal temperature which is then displayed on the application's user interface. The Body Temperature Software (BTS) is a pre-installed application on the Pixel 8 Pro with Android 14 operating system release or higher.
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