FDA Cleared

The AlfaSight 9000 received 510(K) clearance through the
FDA Division of Radiological Health.

The AlfaSight 9000 is FDA cleared, for wide ranges of problems including inflammatory and neoplastic conditions. This means that as long as it is being used as an adjunct to other testing methods such as laboratory, imaging, etc., you are performing conventionally legitimate testing.

​This can raise an integrative medical professional’s credibility substantially, as many alternative clinics frequently use unapproved devices or ones based on theory and not evaluated properly by radiological experts. Alfa has been shown and accepted by the FDA’s Department of Radiological Devices.

Note: many Infrared cameras, now no longer accepted by conventional radiologists, are not cleared properly nor are they calibrated according to the human body. Alfa’s sensors are doubly cleared (there are two sensing mechanisms) and are both calibrated to the human skin temperature ranges.

FDA CLEARANCE

Indications for Use

The AlfaSight 9000 is cleared for marketing and sales in the United States for the adjunct diagnosis of:

  • Abnormalities of the female breast
  • Peripheral vascular disease
  • Musculoskeletal disorders
  • Extracranial cerebral and facial vascular disease
  • Abnormalities of the thyroid gland
  • Various neoplastic conditions

The AlfaSight 9000 is not intended to serve as a sole diagnostic screening procedure. It is intended as an adjunct diagnostic device only. Thermometry is not a replacement for Mammography or any other imaging method, rather it is to be used in conjunction with conventional testing to provide a physiological perspective.

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