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The AG Thermographic Camera(Model no.: ATIR M301) is intended to use as an adjunct to other clinical diagnostic procedures by quantifying differences in skin surface temperature changes. It can visualize and digitalize body surface temperature distribution and temperature changes. The device is intended for use by qualified healthcare personnel trained in its use.

The AG Thermographic Camera (Model no.: ATIR-M301) consists of an infrared camera, accessories, and PC visualization/analysis software. It is a non-contact, non-invasive, and non-radiating infrared system capable of imaging and storing thermal patterns generated by the human body. It employs passive infrared emission sensing technology to capture the thermal data and uses proprietary software to display the temperature distribution pattern as an image.

This document describes the AG Thermographic Camera, Model no.: ATIR-M301, a telethermographic system.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document lists performance tests conducted, implying these serve as acceptance criteria. The specific numerical acceptance criteria values are largely absent, except for temperature accuracy.

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