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

Indications for Use

The AlfaSight 9000^TM 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
• extra-cranial cerebral and facial vascular disease
• abnormalities of the thyroid gland
• various neoplastic and inflammatory conditions

The AlfaSight 9000^TM 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.