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FDA Clearance

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

Indications for Use

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

  1. abnormalities of the female breast
  2. peripheral vascular disease
  3. musculoskeletal disorders
  4. extra-cranial cerebral and facial vascular disease
  5. abnormalities of the thyroid gland
  6. various neoplastic and inflammatory 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.