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:
- 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 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.