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Breast Screening Procedure



This procedure is totally painless and there is no compression or contact with the body. The test is non invasive, uses no radiation, and is F.D.A regulated.

The device classification is Class I (adjunctive use) - 510(k) required

Telethermography systems are regulated as a medical device under 21 CFR 884.2980 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=884.2980). The device classification is: Class I (adjunctive use) - 510(k) required

(a) Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses –
(1) Identification. A telethermographic system for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories
(2) Classification. Class I (general controls.




A Breast screening program should include:

- Mammography, when considered appropriate for women who are eligible for screening.
- Breast thermography as an adjunct for women of all ages.
- A regular breast examination by a health professional.
- Monthly breast self-examination.
- Personal awareness for changes in the breasts.
- Readiness to discuss quickly any such changes with a doctor.

These guidelines should be considered along with your background and medical history.