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