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Thermal Imaging (Infrared Thermographic Systems / …

    https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/thermal-imaging-systems-infrared-thermographic-systems-thermal-imaging-cameras
    The FDA issued the Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health …

Breast Cancer Screening: Thermogram No Substitute for …

    https://www.fda.gov/consumers/consumer-updates/breast-cancer-screening-thermogram-no-substitute-mammogram
    Thermography devices have only been cleared by the FDA as an “adjunctive” tool, referring to use alongside a primary screening test like …

Improper Use of Thermal Imaging Devices: FDA Safety …

    https://www.fda.gov/medical-devices/safety-communications/improper-use-thermal-imaging-devices-fda-safety-communication
    Date Issued: March 4, 2021 The U.S. Food and Drug Administration (FDA) is alerting consumers, health care providers and other users of thermal imaging systems intended …

FDA Alerts Public about Improper Use of Thermal …

    https://www.fda.gov/news-events/press-announcements/fda-alerts-public-about-improper-use-thermal-imaging-devices-warns-firms-illegally-offering-thermal
    The U.S. Food and Drug Administration today alerted consumers, health care providers and other users of thermal imaging systems intended to measure human body …

Non-contact Infrared Thermometers | FDA

    https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/non-contact-infrared-thermometers

    FDA should pull the plug on thermography | Science …

      https://sciencebasedmedicine.org/fda-should-pull-the-plug-on-thermography/
      TTI’s website also says that thermography “is an FDA approved adjunctive diagnostic device so the results can be trusted.” Actually, thermography devices are FDA-cleared, not approved, a …

    FDA issues warning letter to clinic illegally marketing …

      https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letter-clinic-illegally-marketing-unapproved-thermography-device-warns-consumers
      “The FDA is concerned that patients will rely on unapproved claims that thermography may be used as a sole screening device for breast cancer and not get screened with …

    Total Thermal Imaging, Inc. - 567742 - 02/22/2019 | FDA

      https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/total-thermal-imaging-inc-567742-02222019
      Medical Devices Recipient: Linda Hayes President Total Thermal Imaging, Inc. 8341 La Mesa Blvd La Mesa, CA 91942-0217 United States Issuing Office: Center for Devices and …

    FDA issues warning letter to a thermography clinic for …

      https://abcnews.go.com/GMA/Wellness/fda-issues-warning-letter-thermography-clinic-improperly-selling/story?id=61340182
      Thermography is a type of infrared screening used to detect blood flow within the body and is approved by the FDA, but only as an adjunct to a primary test, like mammography, which is considered by …

    Computed Tomography (CT) | FDA

      https://www.fda.gov/radiation-emitting-products/medical-x-ray-imaging/computed-tomography-ct
      The FDA has regulations covering the safety and effectiveness and radiation control of all X-ray imaging devices, including CT. Individual states and other federal agencies regulate …



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