Thermograph, Medical

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K760999 ↗

FDA Product Code

IYM

Device Class

Class III

Regulation

21 CFR Part 884.2980

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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• What clinical specialties is this device primarily intended for based on its regulatory classification and advisory committee review?

  The Thermograph, Medical is primarily intended for use in obstetrics and gynecology, as indicated by its FDA classification under regulation 884.2980 and its review by the Obstetrics/Gynecology (OB) advisory committee. This device uses infrared technology to capture thermal images for non-invasive physiological temperature assessments in these specialties.

• Is this device single-use or reusable, and what does that mean for its maintenance and cleaning?

  The Thermograph, Medical is designed as a reusable medical instrument. This means it must be properly cleaned, disinfected, and maintained between uses to ensure hygiene and functionality, as it is intended for repeated clinical applications in settings requiring thermal imaging.

• How was the FDA clearance for this device determined, and what does the ‘Substantially Equivalent’ decision mean?

  The Thermograph, Medical received FDA clearance through a traditional 510(k) pathway with the decision code SESE, meaning it was determined to be *substantially equivalent* to a legally marketed device in terms of technology and intended use. This classification ensures it meets safety and effectiveness standards for its designated use in obstetrics and gynecology.

• What does the ‘Class III’ regulatory classification imply about the device’s risk level and oversight?

  The Thermograph, Medical is classified as Class III, which indicates it poses higher potential risks and requires stringent regulatory oversight. This classification typically applies to devices supporting or sustaining life, preventing impairment, or presenting a risk of illness/death if they fail. While the device itself is not explicitly described as life-supporting, its classification reflects the FDA’s assessment of its role in critical diagnostic contexts.